Rubiconverse·3 hours ago
3 hours ago
Manager
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What you'll do
- 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 setup.
What they're looking for
- B.S/M.S in Pharmaceutical Sciences
- Proficiency in Regulatory Affairs.
- Knowledge about Pharmaceutical Product Development.
- Excellent communication, planning, analytical and interpersonal skills.
Nice to have
- Prior work experience with Health Canada is preferred.
Summarised by NextRaise from the employer’s description, which follows in full below.
Full description from employer
| Purpose | This position willbe responsible for regulatory product registration filings in key markets including Canada, UK/EU and AU and willneed to supportUS filings as required. The role will involve compilation of dossiers for filing in key markets, responding to queries from the regulatory agencies, and interacting withstakeholders. This position will also be responsible for managing regulatory communications with HealthCanada. |
| Position / JobTitle | Manager |
| Department | Regulatory Affairs |
| Reporting To | AGM/GM – Regulatory Affairs (Key Markets) |
| Location | Ontario |
| Years of Experience | 10-12 years |
Job Responsibilities / Deliverables |
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| Qualifications &Pre- Requisites |
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Company
Rubiconverse
canada
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