- Assist in the preparation and compilation of regulatory submissions (e.g., NDSs, SNDSs, CTAs, Level III, NCs).
- Support the preparation and review of responses to Health Canada questions and queries in a timely manner.
- Participate and assist in Health Canada meetings for assigned products, including preparation of meeting-related materials and logistics.
- Prepare Product Monograph updates for labelling, comply with CCDS, and manage internal labelling updates through GLAMS.
- Assist Associate Director and Manager in negotiations with Health Canada during the review cycle to secure prompt regulatory approval and optimal labelling.
- Collaborate with local and global teams to facilitate regulatory activities.
- Support the development and implementation of regulatory strategies for marketed and developmental products.
- Identify and evaluate potential regulatory risks, providing guidance to cross‑functional teams to align strategies with corporate objectives.
- Maintain SOPs across the regulatory functional area.
- Establish and maintain close communications with Health Canada, cross‑functional partners, and global colleagues.
- Perform other Regulatory Affairs duties as required.
- Participate in global, cross‑functional, and departmental initiatives.
- Adhere to all corporate policies and procedures.
- 1+ year of experience in pharmaceutical Regulatory Affairs.
- Basic understanding of drug development and commercialization process.
- Strong organizational, attention to detail, and project management skills.
- Strong written, verbal, and presentation skills.
- Ability to balance short‑ and long‑term goals.
- Proactive, constantly seeking learning and development.
- Collaborative, works well in a team.
- B.Sc. in Life Science or a relevant scientific field (e.g., pharmacology, toxicology, chemistry).
- Regulatory Affairs Certificate.
- English.
- French.
-
Title: · Specialist, Regulatory AffairsCompany: · Ipsen Biopharmaceuticals Canada Inc.About Ipsen: · Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas: Oncology, Rare Disease and Neuroscience. Supported by ne ...
Mississauga3 days ago
-
Regulatory Affairs is responsible for ensuring that company activities comply with Canadian regulatory requirements throughout the product life cycle. The team works closely with internal and external partners to support regulatory submissions, clinical trial activities, and ongo ...
Mississauga $31,980 - $79,950 (CAD) Internship1 day ago
-
Site Name: Mississauga Milverton Drive · Posted Date: Mar 9 2026 · Regulatory Affairs is responsible for ensuring that company activities comply with Canadian regulatory requirements throughout the product life cycle. The team works closely with internal and external partners to ...
Mississauga $31,980 - $79,950 (CAD) InternshipSHIP1 day ago
-
Are you passionate about regulatory affairs and ensuring compliance in the pharmaceutical industry? · Do you have a strong strategic vision and leadership skills to drive in an unordinary way? If so, we invite you to join our team as Regulatory Affairs Manager at Novo Nordisk Can ...
Mississauga3 weeks ago
-
This entry-level opportunity is ideal for someone eager to begin their regulatory affairs career in a fast-paced, collaborative environment. As a Regulatory Affairs Intern, you will support BD's Canadian operations by contributing to regulatory submissions, market authorizations ...
Mississauga1 month ago
-
Site Name: Mississauga Milverton Drive · Posted Date: Mar 9 2026 · Regulatory Affairs is responsible for ensuring that company activities comply with Canadian regulatory requirements throughout the product life cycle. The team works closely with internal and external partners to ...
Mississauga, ON LR G $65,000 - $95,000 (CAD) per year InternshipSHIP1 day ago
-
The Regulatory Affairs Chapter is committed to ensuring patients have access to improved outcomes more quickly. · Supports the Regulatory Affairs team in the preparation of various regulatory submissions to Health Canada · ...
Mississauga, Ontario1 month ago
-
Overview · The role of Associate Scientist, Regulatory Affairs, is responsible for ensuring faultless regulatory compliance of ingredients, formulas and labelling for several PepsiCo Canada brands. The Regulatory Affairs team is critical to the innovation/renovation process from ...
Mississauga, Ontario2 weeks ago
-
Overview · The role of Associate Scientist, Regulatory Affairs, is responsible for ensuring faultless regulatory compliance of ingredients, formulas and labelling for several PepsiCo Canada brands. The Regulatory Affairs team is critical to the innovation/renovation process from ...
Mississauga, Ontario2 weeks ago
-
Supports the Regulatory Affairs team in the preparation of various regulatory submissions to Health Canada and collaborates with external partners to shape regulatory policies. · ...
Mississauga $57,416 - $75,358 (CAD)1 month ago
-
Develop and execute the regulatory strategy for SUN Innovative Medicines (IM) in-line and pipeline portfolios in Canada. Effectively represent GRA at national and international level across levels (from CEO to junior staff). Accountable/responsible for developing and implementing ...
Mississauga, Ontario1 month ago
-
Primary Responsibilities: · The mandate of the Submission Associate (SA) role is to support various regulatory submission related activities and other projects within the Regulatory Department. The role will require the incumbent to contribute to Health Canada submissions, timel ...
Mississauga $31,980 - $79,950 (CAD) Full time21 hours ago
-
The Regulatory Affairs Chapter is committed to ensuring patients have access to improved outcomes more quickly. Our strategic focus is on building, submitting, and obtaining approvals for clinical trial applications, new drug submissions, and new indications. · ...
Mississauga $57,416 - $75,358 (CAD) Full time1 month ago
-
Site Name: Mississauga Milverton Drive · Posted Date: Mar · Primary Responsibilities: · The mandate of the Submission Associate (SA) role is to support various regulatory submission related activities and other projects within the Regulatory Department. The role will require the ...
Mississauga $31,980 - $79,950 (CAD)13 hours ago
-
+You will lead regulatory CMC (Chemistry, Manufacturing and Controls) activities in Canada to support product development and lifecycle maintenance. You will work with cross-functional teams including R&D, Quality, Manufacturing and Commercial to build clear regulatory strategies ...
Mississauga $111,000 - $161,000 (CAD)1 month ago
-
+This role will support the planning and preparation of regulatory filings and ensure timely submissions to Health Canada with optimal labelling and approval obtained within designated timelines. · ...
Mississauga, ON2 weeks ago
-
You will lead regulatory CMC activities in Canada to support product development and lifecycle maintenance.You will work with cross-functional teams including R&D, Quality, Manufacturing and Commercial to build clear regulatory strategies and prepare submissions. · ...
Mississauga $111,000 - $161,000 (CAD)1 month ago
-
You will lead regulatory CMC activities in Canada to support product development and lifecycle maintenance. · Develop and execute CMC regulatory strategies for product development and lifecycle activities in Canada. · Prepare review and submit CMC sections for regulatory filings ...
Mississauga $111,000 - $161,000 (CAD) Full time1 month ago
-
You will lead regulatory CMC (Chemistry, Manufacturing and Controls) activities in Canada to support product development and lifecycle maintenance. · Develop and execute CMC regulatory strategies for product development and lifecycle activities in Canada. · Prepare, review and su ...
Mississauga $111,000 - $161,000 (CAD) Full time1 month ago
-
We value people who are collaborative, curious, and focused on practical solutions. · Develop and execute CMC regulatory strategies for product development and lifecycle activities in Canada. · Prepare, review and submit CMC sections for regulatory filings, · ...
Mississauga $111,000 - $161,000 (CAD) Full time1 month ago
-
You will lead regulatory CMC activities in Canada to support product development and lifecycle maintenance. · - Develop and execute CMC regulatory strategies for product development and lifecycle activities in Canada.<- Prepare review and submit CMC sections for regulatory filing ...
Mississauga $111,000 - $161,000 (CAD) Full time1 month ago
Specialist, Regulatory Affairs - Mississauga - Ipsen
Description
Specialist, Regulatory Affairs
Join to apply for the Specialist, Regulatory Affairs role at Ipsen.
Summary
As a Specialist, Regulatory Affairs, you will support the Associate Director and Manager of Regulatory Affairs and oversee submission operations across all therapy areas. You will manage a portfolio of projects for approved Ipsen products and the lifecycle of the pipeline in Canada, ensuring timely and compliant regulatory filings to Health Canada. The role maintains strong relationships with Health Canada and internal/external stakeholders, and provides operational support for special projects.
Main Responsibilities & Technical Competencies
Knowledge & Experience (essential)
Education / Certifications (essential)
Education / Certifications (preferred)
Language(s) (essential)
Language(s) (preferred)
Seniority level
Not Applicable
Employment type
Full‑time
Job function
Legal
Industries
Pharmaceutical Manufacturing
#J-18808-Ljbffr
-
Specialist, Regulatory Affairs
Only for registered members Mississauga
-
Regulatory Affairs Associate
Internship Only for registered members Mississauga
-
Regulatory Affairs Associate
InternshipSHIP Only for registered members Mississauga
-
Regulatory Affairs Manager
Only for registered members Mississauga
-
Regulatory Affairs Intern
Only for registered members Mississauga
-
Regulatory Affairs Associate
InternshipSHIP Only for registered members Mississauga, ON LR G
-
2026 - Regulatory Affairs Intern
Only for registered members Mississauga, Ontario
-
Associate Scientist, Regulatory Affairs
Only for registered members Mississauga, Ontario
-
Associate Scientist, Regulatory Affairs
Only for registered members Mississauga, Ontario
-
2026 - Regulatory Affairs Intern
Only for registered members Mississauga
-
Director, Global Regulatory Affairs
Only for registered members Mississauga, Ontario
-
Regulatory Affairs Submission Associate
Full time Only for registered members Mississauga
-
2026 - Regulatory Affairs Intern
Full time Only for registered members Mississauga
-
Regulatory Affairs Submission Associate
Only for registered members Mississauga
-
Regulatory Affairs Manager, CMC
Only for registered members Mississauga
-
Specialist, Regulatory Affairs
Only for registered members Mississauga, ON
-
Regulatory Affairs Manager, CMC
Only for registered members Mississauga
-
Regulatory Affairs Manager, CMC
Full time Only for registered members Mississauga
-
Regulatory Affairs Manager, CMC
Full time Only for registered members Mississauga
-
Regulatory Affairs Manager, CMC
Full time Only for registered members Mississauga
-
Regulatory Affairs Manager, CMC
Full time Only for registered members Mississauga