Purpose
This position will be responsible for regulatory product registration filings in key markets including Canada, UK/EU and AU and will need to support US filings as required. The role will involve compilation of dossiers for filing in key markets, responding to queries from the regulatory agencies, and interacting with stakeholders. This position will also be responsible for managing regulatory communications with Health Canada.
Position / Job Title - Manager
Department -Regulatory Affairs
Reporting To- AGM/GM – Regulatory Affairs (Key Markets)
Location- Ontario
Years of Experience- 10-12 years
Job Responsibilities / Deliverables
- Compilation of dossiers for filings in key markets including Canada, UK/EU and AU for generic and new products.
- Responding to queries from regulatory agencies.
- Co-ordinate with stakeholders and cross-functional team for filing documents and data.
- Manage product registration filings in key markets.
- Manage communications with Health Canada.
- Manage meetings and discussions with Health Canada.
- Support as needed, US filings in the pre-approval or post approval space.
- Coordinate with global regulatory teams.
- Ensure business growth and operational excellence within regulatory set up.
Qualifications & Pre-Requisites
- B.S/M.S in Pharmaceutical Sciences
- Proficiency in Regulatory Affairs.
- Knowledge about Pharmaceutical Product Development.
- Excellent communication, planning, analytical and interpersonal skills.
- Prior work experience with Health Canada is preferred
Job Type: Full-time
Pay: $100,000.00-$110,000.00 per year
Benefits:
- Dental care
- Extended health care
- Life insurance
- On-site parking
Application question(s):
- Experience in regulatory product registration filings
- Experience in compilation of dossiers for filings in key markets including Canada, UK/EU and AU for generic and new products.
Work Location: Remote
