
Regulatory Affairs Career
2 days ago
The role of the Regulatory Affairs Associate I is a vital component in ensuring our products meet regulatory requirements.
This includes:
- Evaluating change controls for registration impact and implementing necessary dossier changes in Europe and International Markets.
Key Responsibilities:
- Compile variation packages for products in the portfolio in collaboration with relevant stakeholders.
Additional Duties:
- Manage regulatory databases and Trackwise system efficiently.
Candidate Requirements:
- Achieve an academic degree with a chemical/pharmaceutical background.
Essential Skills:
- Prioritize tasks effectively and adhere to timelines.
- Familiarity with registration procedures and pharmaceutical regulations.
- Problem-solving abilities and implementation of process improvements.
Reporting Structure: Reports to Senior Manager CMC Regulatory Affairs
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