26 days ago
We are currently working with a very large pharmaceutical client, listed as one of the top 20 Pharmaceutical companies. This particular company is in the middle of an exceedingly exciting growth phase. The title for this role is based on experience, the right candidate has the opportunity to join the team as a Senior Manager or an Associate Director.
Your main responsibilities as a CMC Regulatory Affairs Senior Manager/Associate Director within the Biologics department is to provide insight for Biologic products within the CMC department. You will strengthen scientific arguments (IMPD’s/IND’s/BLA’s and MAA’s).
Education and Experience:
- Minimum 4+ Years in the pharmaceutical industry (6+ Preferred)
- Minimum 2+ years CMC Experience within biologics department
- Knowledge of development/manufacture/analytical aspects of biologics
- Preparation and briefing of Regulatory submissions
- BLA Module 2.3 and 3.0 knowledge
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