Senior Regulatory CMC Specialist
A global pharmaceutical leader is seeking a highly skilled Senior Regulatory Affairs Specialist (CMC) to support a diverse portfolio of biologics, pharmaceuticals, and combination products. In this role, you will drive CMC regulatory strategy, lead preparation of high‑quality submissions, and ensure full compliance with U.S. and international regulatory requirements. This position offers the opportunity to shape regulatory outcomes, influence key decision-making, and contribute directly to the advancement of innovative therapies in a fast‑moving, science‑driven environment.
Key Responsibilities
- Develop CMC regulatory strategies for new and modified products.
- Lead preparation, authoring, and assembly of CMC sections for submissions to FDA, Health Canada, and other agencies.
- Assess CMC‑related changes (manufacturing, process, packaging, sterilization, labeling) for regulatory impact and submission needs.
- Guide testing plans, data requirements, and documentation to support regulatory filings.
- Prepare responses to regulatory agency questions and support interactions throughout the review process.
- Maintain up‑to‑date knowledge of North American CMC regulations, guidelines, and standards.
- Provide CMC regulatory guidance to cross‑functional teams and ensure compliance across development and lifecycle activities.
- Review product labeling for regulatory accuracy and support promotional review as needed.
- Identify regulatory risks, anticipate obstacles, and propose CMC regulatory solutions.
- Support continuous improvement of regulatory processes and documentation standards.
Qualifications
- Bachelor's degree in physical/biological sciences or engineering preferred.
- 3-5 years of Regulatory CMC experience.
- Experience authoring post-market regulatory submissions for biologics and/or combination devices.
- Strong working knowledge of FDA and global regulations for medical devices, pharmaceuticals, and/or biologics.
Certifications
- Regulatory Affairs Certification (RAC) preferred.
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