- Responsible for providing regulatory CMC support through the product life cycle (e.g., regulatory strategies, submission timeline development, change control and preparing submission documents).
- Create high quality, compliant CMC regulatory documents (eg, Core Dossiers, INDs, CTAs, MAAs, BLA, Variations and other relevant regulatory CMC filings) and support client in responding to health authority questions within defined timelines
- Perform assessment of CMC changes, identifying global regulatory requirements, and evaluating supporting documentation to assess acceptability and identify potential risks.
- Responsible for regulatory operational activities including organizing, tracking and sending submissions for publishing for US and other International Markets.
- Compiles documentation for regulatory submission packages including license renewals, updates and market registration for review and submission to regulatory agencies.
- Proactively ensure all regulatory documents are prepared accurately and completed in a timely manner towards project completion.
- Perform Technical review of certificate of analysis, analytical test methods, specification, and stability protocol/report/data.
- Maintains knowledge of current FDA, EU, global regulations and guidance applicable to marketed products.
- Support and prepare other CMC ad-hoc requests as per client requests.
Education and Experience:
- A minimum of B.S. Degree in a scientific or life sciences discipline with a minimum of 1-2 year’s experience in the areas of Regulatory-CMC, research, manufacturing, analytical development and quality environment for biologics/pharmaceutical products.
- Excellent written and verbal communication skills as well as interpersonal skills
- Demonstrated ability to prioritize and manage multiple projects with minimal supervision.
- Proficient ability to read, analyze and interpret technical documents and health authority regulations.
- Experience in eCTD (electronic common technical document) is a plus.
- Prior experience authoring CMC sections in Module 1 and Module 3 sections of regulatory filings.
- Working knowledge of the US and European regulations and ICH guidance is a plus.
- Boston, Philadelphia, and/or New Jersey with a possibility to work remotely
Job Category: Consultant
Job Type: Full Time