Regulatory Affairs Expert
7 days ago
We are seeking an experienced Regulatory Affairs Professional to support our team. The primary responsibility of the position will be Regulatory and Chemistry, Manufacturing, and Controls (CMC) development activities in support of U.S. and ex-U.S. regulatory filings for both internal projects and with partners/alliances.
Main Responsibilities:- Development and oversight of CMC strategy and risk assessments, ensuring compliance with U.S. and international regulatory requirements.
- Review, approval, and release of the CMC section of high-volume regulatory submissions, including drug substance and drug product dossiers.
- Closely collaborate with Manufacturing to resolve complex CMC issues and to support process changes.
- Develop, recommend, and communicate strategic direction and best possible regulatory position to achieve desired outcomes.
- Interact and strategically negotiate with representatives from Regulatory Agencies to assure that appropriate and pragmatic positions can be negotiated with the highest probability of success.
- Bachelor's degree in a relevant field such as chemistry, animal science, life sciences, agriculture, or a related discipline is required.
- A minimum of 3-5 years of pharmaceutical regulatory experience.
- Experience within the animal health pharmaceutical industry.
- Strong knowledge of the US FDA Center for Veterinary Medicine guidance documents.
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