
Global Regulatory Compliance Specialist
1 day ago
Job Title: Regulatory Affairs Associate I
About the Role:
We are seeking a highly motivated and detail-oriented Regulatory Affairs Associate I to join our team. As a key member of our regulatory affairs department, you will play a critical role in ensuring compliance with regulatory requirements and developing strategies to mitigate potential risks.
Key Responsibilities:
- Evaluate change controls for registration impact and ensure implementation of necessary dossier changes in Europe and International Markets.
- Compile variation packages for products in the portfolio in collaboration with relevant stakeholders.
- Manage regulatory databases and Trackwise system efficiently.
Requirements:
- Academic degree with a chemical/pharmaceutical background.
- 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:
This role reports directly to our Senior Manager CMC Regulatory Affairs.
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