CMC Regulatory Sciences Specialist

Organization: 
Regeneron
Job Location: 
Rensselaer,NY
Job Description: 

Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron markets medicines for eye diseases, colorectal cancer, and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including hypercholesterolemia, oncology, rheumatoid arthritis, allergic asthma, and atopic dermatitis.

Summary:
Responsible for determining, compiling and summarizing CMC information and numerical data in written form in support of pharmaceutical regulatory submissions.

Essential Duties and Responsibilities include, but are not limited to, the following:
- Prepares CMC sections of new drug submissions, amendments and other regulatory documents for US, Canada, and other international health authorities.
- Independently prepares or assists with the preparation of a variety of documents to support all phases of clinical drug development. Responsible for review and revision of product lifecycle documents including, but not limited to, SOPs, validation protocols and reports, and process development reports.
- Rewrites various sources of information into a uniform style and language for regulatory compliance, and assists in developing documentation for instructional, descriptive, reference, and/or informational purposes.
- Collaborates with research and development and manufacturing personnel in the preparation and review of documents; providing feedback on format and content and guidance in general. Keeps management and others informed on progress of documents.

Education and Experience:
- Requires a BS/BA in a scientific discipline.
- Experience with or knowledge of biopharmaceutical equipment or manufacturing preferred.

Title level (Associate, Mid-level, or Sr.) will be determined based on skills and experience.

We offer a competitive compensation and benefits package including stock incentives, 401k with company match, as well as the expected health and welfare benefits. Comprehensive relocation benefits are available, as required.

Regeneron is an equal opportunity employer and is an affirmative action employer.

To view the full job description, please visit our website at www.regeneron.com

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