Manager / Sr Manager CMC Regulatory Sciences

Rensselaer, New York, US
Oct 06, 2018
Required Education
Bachelors Degree
Position Type
Full time
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 commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases.

Summary: This individual will provide expertise in translating scientific documents into well thought out, clearly written regulatory submissions.

Essential Duties and Responsibilities include, but are not limited to, the following:

• Provides direction, regulatory, and technical writing expertise on the coordination, preparation and timely submissions of CMC content of global regulatory documents including BLA/MAA, IND/IMPD, responses to information requests and related documents.

• Coordinates with Quality, Manufacturing and Supply organizations on the planning and submission of CMC regulatory documents to support product life cycle management.

• Reviews and edits CMC documents as needed.

• Ensures the accuracy, interpretation, and clarity of written technical information/communications and ensures all documents will meet regulatory requirements.

• Maintains up-to-date knowledge of current and emerging regulations, guidance documents and corporate/industry standards.

• Ensures the timely review and approval of submission components with the designated review teams.

• Directs team of Technical Writers.
Education and Experience:

• Requires BS/BA in Chemistry, Biology or related field (advanced degree preferred) with at least 7+ years experience working in the biopharmaceutical manufacturing industry including 5+ years experience writing CMC regulatory documents.

• Leadership and/or managerial experience required.

This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business.

To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.