142 Financial Regulations jobs in Canada

Associate, Regulatory Affairs

Sun Pharmaceuticals, Inc

Posted 4 days ago

Job Viewed

Tap Again To Close

Job Description

**Job purpose**
The **Regulatory Affairs Associate** is responsible for supporting new drug product registrations and maintaining current drug product registrations for our Canadian Brand Specialty portfolio. This role plays a pivotal part in ensuring regulatory compliance, timely submissions, and successful approvals from Health Canada.
**Duties and responsibilities**
+ Assist with planning, preparing, coordinating, compiling, reviewing and submitting regulatory dossiers (e.g., NDS, SNDS, NC, Level III Changes) to Health Canada
+ Prepare responses to Health Canada clarification requests in a timely manner throughout the submission lifecycle
+ Maintain current drug product registrations and support post-approval regulatory activities
+ Review product packaging, labeling, and promotional materials for compliance
+ Review change controls and assess impact of regulatory updates and support implementation of necessary changes
+ Track submission milestones and post-approval commitments
+ Support product launch activities from a regulatory perspective
+ Support regulatory strategy development for new product filings and lifecycle management
+ Monitor and interpret changes in Canadian regulatory guidance
+ Maintain accurate and organized regulatory documentation
+ Work closely with departments including Quality, R&D, Marketing, and Supply Chain
+ Other regulatory responsibilities as required by the Director
**Additional responsibility (Only applicable to customer facing roles)**
+ Report any adverse event received from customers for company products to the pharmacovigilance/drug safety department within 1 business day
**Qualifications**
**Knowledge, Skills and Abilities:**
+ Familiarity with Health Canada regulatory guidelines and submission processes (including chemistry and manufacturing, labeling and format requirements)
+ Ability to interpret regulations and create compliant documentation
+ Strong interpersonal, written and verbal communication skills
+ Excellent organizational and time-management abilities to adhere to submission timelines
+ Comfortable working on multiple priorities and deadlines
+ High attention to detail and accuracy
+ Collaborative and adaptable in fast-paced environments
+ Proactive problem-solving mindset with a focus on compliance and quality
+ Proficiency with Microsoft Office tools (Word, Excel, PowerPoint), Adobe Acrobat and document management systems
+ Knowledge of GMP requirements and QA/QC procedures
**Background and Experience:**
+ Bachelors degree in Life Sciences, Pharmacy, Chemistry, or a related field
+ Postgraduate studies or certification in Regulatory Affairs (e.g., RAPS, TOPRA) is an asset
+ 3 or greater years of drug or drug/device regulatory affairs experience within the pharmaceutical or healthcare industry
**Working conditions**
+ Local Canadian office
+ Extensive use of computer
+ Varied work schedule to meet deadlines, as required
**Physical requirements**
+ Hybrid role (in office at least 3 days a week)
**Direct reports**
NA
We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.
This advertiser has chosen not to accept applicants from your region.

Regulatory Affairs Coordinator

Montréal, Quebec Moroccanoil

Posted 2 days ago

Job Viewed

Tap Again To Close

Job Description

About the Company:


Inspired by the Mediterranean, Moroccanoil comes to life through our iconic turquoise packaging and signature fragrance, for an exotic experience that transports the senses. Our original Moroccanoil Treatment pioneered oil-infused haircare and sparked global interest in argan oil. At the heart of our brand is the stylist community that inspires us to create effective and easy-to-use products.

Today, our mission remains unchanged: to pioneer beauty innovations while making a positive impact. We support animal welfare as a cruelty-free brand with our PETA Beauty without Bunnies certification and partnership with the Humane Society. Ocean conservation and sustainability are central to us, including our collaboration with Oceana. As our journey continues, we strive to make a meaningful difference in our communities and around the world.


Requirements

Key responsibilities involve:

  • Performing regulatory reviews on raw materials, formulations and packaging to confirm compliance with all relevant regulations with particular emphasis on US FDA and Health Canada, and ensuring all products offered meet required standards and regulations.
  • Working closely with Product Development and Marketing departments to provide regulatory input on projects related to new developments or changes to existing products from the point of view of regulatory framework and compliance.
  • Providing support to Marketing team to ensure all product claims are substantiated properly to comply with regulations.
  • Ensuring product testing protocols comply with regulatory requirements or defined industry standards.
  • Constantly monitoring, analyzing and providing impact assessment on all regulatory changes in different markets and communicates this information with relevant departments including Product Development and Production to ensure company remains complaint with all regulations over time.


Qualifications:

  • 1 to 4 years of work experience in similar or relevant field, preferably in the cosmetic industry.
  • Knowledge of US FDA cosmetic and OTC products regulations, the Food Drug and Cosmetic Act (FD&C), The Fair Packaging and Labeling Act (FPLA), California Prop 65 and other relevant local, state and federal regulations.
  • Knowledge of Health Canada regulations and notification process.
  • Ability to understand and analyze safety assessment reports.
  • Knowledge of global INCI databases.
  • Demonstrates excellent verbal and written communications skills in English; French and/or Hebrew an asset.
  • Able to take initiative, and ability to lead and collaborate depending on the project.
  • Flexibility and agility to accommodate constant project changes and time constraints.
  • Willing to engage as a member of a global team with members in several different time zones and schedules.


Education required:

  • Bachelor’s Degree in Chemistry/Biology/related life science degrees. Master’s Degree preferred



À propos de l’entreprise :

Inspirée par la Méditerranée, Moroccanoil prend vie à travers notre emblématique emballage turquoise et notre fragrance signature, offrant une expérience exotique qui transporte les sens. Notre traitement original Moroccanoil a été le pionnier des soins capillaires infusés à l’huile et a suscité un engouement mondial pour l’huile d’argan. Au cœur de notre marque se trouve la communauté de stylistes qui nous inspire à créer des produits efficaces et faciles à utiliser.

Aujourd’hui, notre mission demeure la même : être à l’avant-garde de l’innovation beauté tout en ayant un impact positif. Nous soutenons le bien-être animal en tant que marque certifiée sans cruauté par PETA grâce à notre certification Beauty Without Bunnies et notre partenariat avec la Humane Society. La conservation des océans et la durabilité sont également essentielles à notre mission, comme en témoigne notre collaboration avec Oceana. Alors que notre parcours se poursuit, nous nous efforçons de faire une différence significative dans nos communautés et à travers le monde.


Exigences

Les principales responsabilités impliquent :

  • La réalisation d’examens réglementaires sur des matières premières, formules et emballages pour veiller à la conformité avec l’ensemble des réglementations pertinentes avec une attention particulière pour la FDA des É.-U. et Santé Canada, et assurer que tous les produits proposés respectent les normes et réglementations.
  • L’étroite collaboration avec les services de Développement de produits et Marketing pour fournir une contribution sur la réglementation pour les projets liés aux nouveaux développements ou aux modifications de produits existants dans le cadre réglementaire et de la conformité.
  • Une assistance auprès de l’équipe marketing pour assurer que toutes les propriétés attribuées aux produits sont correctement corroborées, afin de respecter les réglementations.
  • L’assurance que tous les protocoles de test des produits respectent les exigences réglementaires ou normes industrielles définies.
  • La vérification constante, l’analyse et la réalisation de l’évaluation d’impact sur tous les changements réglementaires dans différents marchés et la communication de cette information aux différents services pertinents, y compris le Développement de produits et la Production, afin de s’assurer que l’entreprise continue de se conformer à toutes les réglementations au fil du temps.


Qualifications:

  • 1 à 4 ans d’expérience professionnelle dans un domaine similaire ou pertinent, de préférence dans le secteur des cosmétiques.
  • Connaissances des réglementations sur les produits cosmétiques et en vente libre de la FDA aux É.-U., du Food Drug and Cosmetic Act (FD&C), du Fair Packaging and Labeling Act (FPLA), du California Proposition 65 et autres réglementations locales, d’État et fédérales pertinentes.
  • Connaissance des réglementations de Santé Canada et du processus de notification.
  • Capacité à comprendre et analyser des rapports d’évaluation de la sûreté.
  • Connaissance de bases de données INCI mondiales.
  • Présenter d’excellentes capacités de communication orale et écrite en anglais (le français et/ou l’hébreu constitue un atout).
  • Capacité à prendre des initiatives et à diriger et collaborer selon le projet.
  • Flexibilité et agilité pour s’adapter à des modifications constantes de projet et contraintes de temps.
  • Envie de s’engager en tant que membre d’une équipe internationale avec des membres dans différents fuseaux horaires et avec différents calendriers.


Formation:

  • Baccalauréat en chimie/biologie/diplômes pertinents en sciences de la vie. Niveau maîtrise préféré
This advertiser has chosen not to accept applicants from your region.

Regulatory Affairs Coordinator

Laval, Quebec Moroccanoil

Posted 2 days ago

Job Viewed

Tap Again To Close

Job Description

About the Company:


Inspired by the Mediterranean, Moroccanoil comes to life through our iconic turquoise packaging and signature fragrance, for an exotic experience that transports the senses. Our original Moroccanoil Treatment pioneered oil-infused haircare and sparked global interest in argan oil. At the heart of our brand is the stylist community that inspires us to create effective and easy-to-use products.

Today, our mission remains unchanged: to pioneer beauty innovations while making a positive impact. We support animal welfare as a cruelty-free brand with our PETA Beauty without Bunnies certification and partnership with the Humane Society. Ocean conservation and sustainability are central to us, including our collaboration with Oceana. As our journey continues, we strive to make a meaningful difference in our communities and around the world.


Requirements

Key responsibilities involve:

  • Performing regulatory reviews on raw materials, formulations and packaging to confirm compliance with all relevant regulations with particular emphasis on US FDA and Health Canada, and ensuring all products offered meet required standards and regulations.
  • Working closely with Product Development and Marketing departments to provide regulatory input on projects related to new developments or changes to existing products from the point of view of regulatory framework and compliance.
  • Providing support to Marketing team to ensure all product claims are substantiated properly to comply with regulations.
  • Ensuring product testing protocols comply with regulatory requirements or defined industry standards.
  • Constantly monitoring, analyzing and providing impact assessment on all regulatory changes in different markets and communicates this information with relevant departments including Product Development and Production to ensure company remains complaint with all regulations over time.


Qualifications:

  • 1 to 4 years of work experience in similar or relevant field, preferably in the cosmetic industry.
  • Knowledge of US FDA cosmetic and OTC products regulations, the Food Drug and Cosmetic Act (FD&C), The Fair Packaging and Labeling Act (FPLA), California Prop 65 and other relevant local, state and federal regulations.
  • Knowledge of Health Canada regulations and notification process.
  • Ability to understand and analyze safety assessment reports.
  • Knowledge of global INCI databases.
  • Demonstrates excellent verbal and written communications skills in English; French and/or Hebrew an asset.
  • Able to take initiative, and ability to lead and collaborate depending on the project.
  • Flexibility and agility to accommodate constant project changes and time constraints.
  • Willing to engage as a member of a global team with members in several different time zones and schedules.


Education required:

  • Bachelor’s Degree in Chemistry/Biology/related life science degrees. Master’s Degree preferred



À propos de l’entreprise :

Inspirée par la Méditerranée, Moroccanoil prend vie à travers notre emblématique emballage turquoise et notre fragrance signature, offrant une expérience exotique qui transporte les sens. Notre traitement original Moroccanoil a été le pionnier des soins capillaires infusés à l’huile et a suscité un engouement mondial pour l’huile d’argan. Au cœur de notre marque se trouve la communauté de stylistes qui nous inspire à créer des produits efficaces et faciles à utiliser.

Aujourd’hui, notre mission demeure la même : être à l’avant-garde de l’innovation beauté tout en ayant un impact positif. Nous soutenons le bien-être animal en tant que marque certifiée sans cruauté par PETA grâce à notre certification Beauty Without Bunnies et notre partenariat avec la Humane Society. La conservation des océans et la durabilité sont également essentielles à notre mission, comme en témoigne notre collaboration avec Oceana. Alors que notre parcours se poursuit, nous nous efforçons de faire une différence significative dans nos communautés et à travers le monde.


Exigences

Les principales responsabilités impliquent :

  • La réalisation d’examens réglementaires sur des matières premières, formules et emballages pour veiller à la conformité avec l’ensemble des réglementations pertinentes avec une attention particulière pour la FDA des É.-U. et Santé Canada, et assurer que tous les produits proposés respectent les normes et réglementations.
  • L’étroite collaboration avec les services de Développement de produits et Marketing pour fournir une contribution sur la réglementation pour les projets liés aux nouveaux développements ou aux modifications de produits existants dans le cadre réglementaire et de la conformité.
  • Une assistance auprès de l’équipe marketing pour assurer que toutes les propriétés attribuées aux produits sont correctement corroborées, afin de respecter les réglementations.
  • L’assurance que tous les protocoles de test des produits respectent les exigences réglementaires ou normes industrielles définies.
  • La vérification constante, l’analyse et la réalisation de l’évaluation d’impact sur tous les changements réglementaires dans différents marchés et la communication de cette information aux différents services pertinents, y compris le Développement de produits et la Production, afin de s’assurer que l’entreprise continue de se conformer à toutes les réglementations au fil du temps.


Qualifications:

  • 1 à 4 ans d’expérience professionnelle dans un domaine similaire ou pertinent, de préférence dans le secteur des cosmétiques.
  • Connaissances des réglementations sur les produits cosmétiques et en vente libre de la FDA aux É.-U., du Food Drug and Cosmetic Act (FD&C), du Fair Packaging and Labeling Act (FPLA), du California Proposition 65 et autres réglementations locales, d’État et fédérales pertinentes.
  • Connaissance des réglementations de Santé Canada et du processus de notification.
  • Capacité à comprendre et analyser des rapports d’évaluation de la sûreté.
  • Connaissance de bases de données INCI mondiales.
  • Présenter d’excellentes capacités de communication orale et écrite en anglais (le français et/ou l’hébreu constitue un atout).
  • Capacité à prendre des initiatives et à diriger et collaborer selon le projet.
  • Flexibilité et agilité pour s’adapter à des modifications constantes de projet et contraintes de temps.
  • Envie de s’engager en tant que membre d’une équipe internationale avec des membres dans différents fuseaux horaires et avec différents calendriers.


Formation:

  • Baccalauréat en chimie/biologie/diplômes pertinents en sciences de la vie. Niveau maîtrise préféré
This advertiser has chosen not to accept applicants from your region.

Regulatory Affairs Coordinator

Longueuil, Quebec Moroccanoil

Posted 2 days ago

Job Viewed

Tap Again To Close

Job Description

About the Company:


Inspired by the Mediterranean, Moroccanoil comes to life through our iconic turquoise packaging and signature fragrance, for an exotic experience that transports the senses. Our original Moroccanoil Treatment pioneered oil-infused haircare and sparked global interest in argan oil. At the heart of our brand is the stylist community that inspires us to create effective and easy-to-use products.

Today, our mission remains unchanged: to pioneer beauty innovations while making a positive impact. We support animal welfare as a cruelty-free brand with our PETA Beauty without Bunnies certification and partnership with the Humane Society. Ocean conservation and sustainability are central to us, including our collaboration with Oceana. As our journey continues, we strive to make a meaningful difference in our communities and around the world.


Requirements

Key responsibilities involve:

  • Performing regulatory reviews on raw materials, formulations and packaging to confirm compliance with all relevant regulations with particular emphasis on US FDA and Health Canada, and ensuring all products offered meet required standards and regulations.
  • Working closely with Product Development and Marketing departments to provide regulatory input on projects related to new developments or changes to existing products from the point of view of regulatory framework and compliance.
  • Providing support to Marketing team to ensure all product claims are substantiated properly to comply with regulations.
  • Ensuring product testing protocols comply with regulatory requirements or defined industry standards.
  • Constantly monitoring, analyzing and providing impact assessment on all regulatory changes in different markets and communicates this information with relevant departments including Product Development and Production to ensure company remains complaint with all regulations over time.


Qualifications:

  • 1 to 4 years of work experience in similar or relevant field, preferably in the cosmetic industry.
  • Knowledge of US FDA cosmetic and OTC products regulations, the Food Drug and Cosmetic Act (FD&C), The Fair Packaging and Labeling Act (FPLA), California Prop 65 and other relevant local, state and federal regulations.
  • Knowledge of Health Canada regulations and notification process.
  • Ability to understand and analyze safety assessment reports.
  • Knowledge of global INCI databases.
  • Demonstrates excellent verbal and written communications skills in English; French and/or Hebrew an asset.
  • Able to take initiative, and ability to lead and collaborate depending on the project.
  • Flexibility and agility to accommodate constant project changes and time constraints.
  • Willing to engage as a member of a global team with members in several different time zones and schedules.


Education required:

  • Bachelor’s Degree in Chemistry/Biology/related life science degrees. Master’s Degree preferred



À propos de l’entreprise :

Inspirée par la Méditerranée, Moroccanoil prend vie à travers notre emblématique emballage turquoise et notre fragrance signature, offrant une expérience exotique qui transporte les sens. Notre traitement original Moroccanoil a été le pionnier des soins capillaires infusés à l’huile et a suscité un engouement mondial pour l’huile d’argan. Au cœur de notre marque se trouve la communauté de stylistes qui nous inspire à créer des produits efficaces et faciles à utiliser.

Aujourd’hui, notre mission demeure la même : être à l’avant-garde de l’innovation beauté tout en ayant un impact positif. Nous soutenons le bien-être animal en tant que marque certifiée sans cruauté par PETA grâce à notre certification Beauty Without Bunnies et notre partenariat avec la Humane Society. La conservation des océans et la durabilité sont également essentielles à notre mission, comme en témoigne notre collaboration avec Oceana. Alors que notre parcours se poursuit, nous nous efforçons de faire une différence significative dans nos communautés et à travers le monde.


Exigences

Les principales responsabilités impliquent :

  • La réalisation d’examens réglementaires sur des matières premières, formules et emballages pour veiller à la conformité avec l’ensemble des réglementations pertinentes avec une attention particulière pour la FDA des É.-U. et Santé Canada, et assurer que tous les produits proposés respectent les normes et réglementations.
  • L’étroite collaboration avec les services de Développement de produits et Marketing pour fournir une contribution sur la réglementation pour les projets liés aux nouveaux développements ou aux modifications de produits existants dans le cadre réglementaire et de la conformité.
  • Une assistance auprès de l’équipe marketing pour assurer que toutes les propriétés attribuées aux produits sont correctement corroborées, afin de respecter les réglementations.
  • L’assurance que tous les protocoles de test des produits respectent les exigences réglementaires ou normes industrielles définies.
  • La vérification constante, l’analyse et la réalisation de l’évaluation d’impact sur tous les changements réglementaires dans différents marchés et la communication de cette information aux différents services pertinents, y compris le Développement de produits et la Production, afin de s’assurer que l’entreprise continue de se conformer à toutes les réglementations au fil du temps.


Qualifications:

  • 1 à 4 ans d’expérience professionnelle dans un domaine similaire ou pertinent, de préférence dans le secteur des cosmétiques.
  • Connaissances des réglementations sur les produits cosmétiques et en vente libre de la FDA aux É.-U., du Food Drug and Cosmetic Act (FD&C), du Fair Packaging and Labeling Act (FPLA), du California Proposition 65 et autres réglementations locales, d’État et fédérales pertinentes.
  • Connaissance des réglementations de Santé Canada et du processus de notification.
  • Capacité à comprendre et analyser des rapports d’évaluation de la sûreté.
  • Connaissance de bases de données INCI mondiales.
  • Présenter d’excellentes capacités de communication orale et écrite en anglais (le français et/ou l’hébreu constitue un atout).
  • Capacité à prendre des initiatives et à diriger et collaborer selon le projet.
  • Flexibilité et agilité pour s’adapter à des modifications constantes de projet et contraintes de temps.
  • Envie de s’engager en tant que membre d’une équipe internationale avec des membres dans différents fuseaux horaires et avec différents calendriers.


Formation:

  • Baccalauréat en chimie/biologie/diplômes pertinents en sciences de la vie. Niveau maîtrise préféré
This advertiser has chosen not to accept applicants from your region.

Senior Director Regulatory Affairs

London, Ontario Brunel

Posted 2 days ago

Job Viewed

Tap Again To Close

Job Description

Introduction

We are currently hiring a Senior Director, Drug Development & Regulatory Strategy for our client, a growing, mission-driven organization in the drug development space. This company focuses on helping bring new therapies to market—faster and smarter—by guiding early-stage drug programs through regulatory milestones.

In this senior leadership position, you’ll oversee regulatory strategy and operations for early-stage drug development, with a focus on first-in-human and first-in-class molecules. You'll manage a talented Regulatory Affairs team and serve as the main point of contact for global health authorities (FDA, Health Canada, EMA).


Responsibilities

  • Shape and lead regulatory strategy for early development programs
  • Consult with clients during pre-award phase to define regulatory needs
  • Lead regulatory content for proposals and client meetings
  • Manage and mentor a high-performing regulatory team
  • Serve as main liaison with regulatory agencies (FDA, Health Canada, EMA)
  • Guide preparation for regulatory meetings (e.g. pre-IND, pre-CTA)
  • Oversee submission content for INDs, CTAs, and other filings
  • Partner with internal teams across Clinical, CDMO, Medical Writing, and Project Management
  • Monitor changing regulations and industry trends
  • Implement best practices and SOPs for compliance and efficiency


Requirements

  • Advanced degree in life sciences or regulatory-related discipline (PhD preferred)
  • 10+ years of Global Regulatory Affairs experience in a CRO, biotech, or pharma environment
  • Proven track record leading early-stage regulatory strategy and submissions
  • Strong knowledge of FDA and Health Canada requirements (IND, CTA)
  • Excellent communication and cross-functional leadership skills
  • Sound scientific and business judgment
  • Understanding of GMP, GLP, and GCP practices


What We Offer

Why apply through Brunel? Finding the next step in your career can be a full-time job in itself. We manage the process for you: from submitting your resume to coordinating interviews to extending offers and assisting with onboarding. We will get you going while you get on with the job.


About Us

Brunel has a reputation for working with some of the best in the business. That is what we continually strive for. Over 45 years, we have created a global network of interesting clients and talented individuals working together through a vast array of services.

This advertiser has chosen not to accept applicants from your region.

Senior Director Regulatory Affairs

La Baie, Quebec Brunel

Posted 2 days ago

Job Viewed

Tap Again To Close

Job Description

Introduction

We are currently hiring a Senior Director, Drug Development & Regulatory Strategy for our client, a growing, mission-driven organization in the drug development space. This company focuses on helping bring new therapies to market—faster and smarter—by guiding early-stage drug programs through regulatory milestones.

In this senior leadership position, you’ll oversee regulatory strategy and operations for early-stage drug development, with a focus on first-in-human and first-in-class molecules. You'll manage a talented Regulatory Affairs team and serve as the main point of contact for global health authorities (FDA, Health Canada, EMA).


Responsibilities

  • Shape and lead regulatory strategy for early development programs
  • Consult with clients during pre-award phase to define regulatory needs
  • Lead regulatory content for proposals and client meetings
  • Manage and mentor a high-performing regulatory team
  • Serve as main liaison with regulatory agencies (FDA, Health Canada, EMA)
  • Guide preparation for regulatory meetings (e.g. pre-IND, pre-CTA)
  • Oversee submission content for INDs, CTAs, and other filings
  • Partner with internal teams across Clinical, CDMO, Medical Writing, and Project Management
  • Monitor changing regulations and industry trends
  • Implement best practices and SOPs for compliance and efficiency


Requirements

  • Advanced degree in life sciences or regulatory-related discipline (PhD preferred)
  • 10+ years of Global Regulatory Affairs experience in a CRO, biotech, or pharma environment
  • Proven track record leading early-stage regulatory strategy and submissions
  • Strong knowledge of FDA and Health Canada requirements (IND, CTA)
  • Excellent communication and cross-functional leadership skills
  • Sound scientific and business judgment
  • Understanding of GMP, GLP, and GCP practices


What We Offer

Why apply through Brunel? Finding the next step in your career can be a full-time job in itself. We manage the process for you: from submitting your resume to coordinating interviews to extending offers and assisting with onboarding. We will get you going while you get on with the job.


About Us

Brunel has a reputation for working with some of the best in the business. That is what we continually strive for. Over 45 years, we have created a global network of interesting clients and talented individuals working together through a vast array of services.

This advertiser has chosen not to accept applicants from your region.

Senior Director Regulatory Affairs

Sherbrooke, Quebec Brunel

Posted 2 days ago

Job Viewed

Tap Again To Close

Job Description

Introduction

We are currently hiring a Senior Director, Drug Development & Regulatory Strategy for our client, a growing, mission-driven organization in the drug development space. This company focuses on helping bring new therapies to market—faster and smarter—by guiding early-stage drug programs through regulatory milestones.

In this senior leadership position, you’ll oversee regulatory strategy and operations for early-stage drug development, with a focus on first-in-human and first-in-class molecules. You'll manage a talented Regulatory Affairs team and serve as the main point of contact for global health authorities (FDA, Health Canada, EMA).


Responsibilities

  • Shape and lead regulatory strategy for early development programs
  • Consult with clients during pre-award phase to define regulatory needs
  • Lead regulatory content for proposals and client meetings
  • Manage and mentor a high-performing regulatory team
  • Serve as main liaison with regulatory agencies (FDA, Health Canada, EMA)
  • Guide preparation for regulatory meetings (e.g. pre-IND, pre-CTA)
  • Oversee submission content for INDs, CTAs, and other filings
  • Partner with internal teams across Clinical, CDMO, Medical Writing, and Project Management
  • Monitor changing regulations and industry trends
  • Implement best practices and SOPs for compliance and efficiency


Requirements

  • Advanced degree in life sciences or regulatory-related discipline (PhD preferred)
  • 10+ years of Global Regulatory Affairs experience in a CRO, biotech, or pharma environment
  • Proven track record leading early-stage regulatory strategy and submissions
  • Strong knowledge of FDA and Health Canada requirements (IND, CTA)
  • Excellent communication and cross-functional leadership skills
  • Sound scientific and business judgment
  • Understanding of GMP, GLP, and GCP practices


What We Offer

Why apply through Brunel? Finding the next step in your career can be a full-time job in itself. We manage the process for you: from submitting your resume to coordinating interviews to extending offers and assisting with onboarding. We will get you going while you get on with the job.


About Us

Brunel has a reputation for working with some of the best in the business. That is what we continually strive for. Over 45 years, we have created a global network of interesting clients and talented individuals working together through a vast array of services.

This advertiser has chosen not to accept applicants from your region.
Be The First To Know

About the latest Financial regulations Jobs in Canada !

 

Nearby Locations

Other Jobs Near Me

Industry

  1. request_quote Accounting
  2. work Administrative
  3. eco Agriculture Forestry
  4. smart_toy AI & Emerging Technologies
  5. school Apprenticeships & Trainee
  6. apartment Architecture
  7. palette Arts & Entertainment
  8. directions_car Automotive
  9. flight_takeoff Aviation
  10. account_balance Banking & Finance
  11. local_florist Beauty & Wellness
  12. restaurant Catering
  13. volunteer_activism Charity & Voluntary
  14. science Chemical Engineering
  15. child_friendly Childcare
  16. foundation Civil Engineering
  17. clean_hands Cleaning & Sanitation
  18. diversity_3 Community & Social Care
  19. construction Construction
  20. brush Creative & Digital
  21. currency_bitcoin Crypto & Blockchain
  22. support_agent Customer Service & Helpdesk
  23. medical_services Dental
  24. medical_services Driving & Transport
  25. medical_services E Commerce & Social Media
  26. school Education & Teaching
  27. electrical_services Electrical Engineering
  28. bolt Energy
  29. local_mall Fmcg
  30. gavel Government & Non Profit
  31. emoji_events Graduate
  32. health_and_safety Healthcare
  33. beach_access Hospitality & Tourism
  34. groups Human Resources
  35. precision_manufacturing Industrial Engineering
  36. security Information Security
  37. handyman Installation & Maintenance
  38. policy Insurance
  39. code IT & Software
  40. gavel Legal
  41. sports_soccer Leisure & Sports
  42. inventory_2 Logistics & Warehousing
  43. supervisor_account Management
  44. supervisor_account Management Consultancy
  45. supervisor_account Manufacturing & Production
  46. campaign Marketing
  47. build Mechanical Engineering
  48. perm_media Media & PR
  49. local_hospital Medical
  50. local_hospital Military & Public Safety
  51. local_hospital Mining
  52. medical_services Nursing
  53. local_gas_station Oil & Gas
  54. biotech Pharmaceutical
  55. checklist_rtl Project Management
  56. shopping_bag Purchasing
  57. home_work Real Estate
  58. person_search Recruitment Consultancy
  59. store Retail
  60. point_of_sale Sales
  61. science Scientific Research & Development
  62. wifi Telecoms
  63. psychology Therapy
  64. pets Veterinary
View All Financial Regulations Jobs