
Regulatory Affairs Associate I
3 weeks ago
Assessment of Change Controls:
- Evaluate change controls for registration impact and ensure implementation of necessary dossier changes in Europe and International Markets.
Variations Compilation:
- Compile variation packages for products in the portfolio in collaboration with relevant stakeholders.
Regulatory Database Management:
- Manage regulatory databases and Trackwise system efficiently.
Experience and Qualifications: Qualifications:
- Academic degree with a chemical/pharmaceutical background.
Experience:
- 2-5 years of experience in CMC Regulatory Affairs, focusing mainly on Europe and International Markets.
- Proficient in registration procedures and pharmaceutical regulations.
- Familiarity with Document Management Systems.
- Strong prioritization skills and ability to adhere to timelines.
- Capable of working independently with moderate guidance.
- Problem-solving abilities and implementation of process improvements.
- Team player mentality.
Reporting Structure:Reports to Senior Manager CMC Regulatory Affairs
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