Senior Manager / Associate Director CMC Regulatory Sciences Operations

Rensselaer, New York, US
Sep 01, 2018
Required Education
Bachelors Degree
Position Type
Full time
Position Summary

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 direct the departmental operations functions in the CMC Regulatory Sciences (CMC RS) Department. These functions include but are not limited to Product Specifications, Document Quality, and Distribution Management within the CMC RS Department.

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

• Oversees operations functions within CMC Regulatory Sciences including Specifications, Document Quality, and Distribution Management. Provides leadership for these functions by:
o Ensuring product quality specifications are created and maintained to support program and business needs.
o Supporting the review of CMC content for accuracy, including data verification, clarity, consistency, and conformance to writing conventions.
o Promoting high writing standards within CMC RS and throughout IOPS through oversight of CMC content copy editing activities and the technical writing training program.
o Supporting the distribution of Regeneron's clinical and commercial material from a CMC Regulatory Sciences Perspective. This includes providing appropriate oversight to ensure batch attributes match the appropriate version of the filed product application, and that product application updates are planned to optimally support Supply Chain needs.

• Keeps management and all stakeholders informed of decisions, overall strategy, and project status.

• Identifies project issues and contributes to the development of alternative CMC Regulatory Sciences strategies.

• Manages and develops staff and direct reports.
Education and Experience:

• Requires BS in Chemistry, Biology or related field (advanced degree preferred) with at least 8 years experience working in the biopharmaceutical or related industry including significant experience in CMC related activities.

• Leadership and/or managerial experience required.

• Experience in managing quality systems and program management is considered a plus.

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.