Auto req ID: 1732BR
Job Posting Title: Associate Manager/Sr. Manager, Regulatory Affairs
Person Type: Regular
Posting Category: CMC Regulatory Sciences
Job Summary and Essential Functions:
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.
Maintaining an active engagement with emerging and current regulatory trends in the industry. In this capacity, the successful senior manager/associate manager will provide day-to-day support to the Director(s) in order to counsel and guide the Industrial Operations and Product Supply (lOPS) team in the decisionmaking process and strategic planning, as well as to support all CMC regulatory filing activities for various preINDs, INDs, IMPDs, CT As and BLAs/MAAs and track regulatory commitments.
Manage timelines in cooperation with project management, lOPS/Tarrytown SMEs and
Tarrytown Regulatory Operations (RegOps) to ensure on-time regulatory submissions.
Assist with the planning, scientific writing and perform critical reviews of a preINDs, INDs, IMPDs, BLAs, MAAs, annual reports, DSUR, amendments, supplements (eCTD) to ensure a high quality regulatory submission and approval and to evaluate conformance with the regulatory requirements.
Coordinate and manage regulatory inspections, as needed, at the Rensselaer site or at other sites if the inspection relates to regulatory CMC issues.
Assist in review of manufacturing change controls by cross-checking the description in regulatory filings in INDs/IMPDs, CTAs and BLAs/MAAs and to ensure that manufacturing changes are reported to competent authorities in accordance with regulatory requirements.
Support establishing, managing and maintaining a knowledge base of current and emerging regulatory requirements and guidelines in the CMC field.
Assist in keep track of regulatory commitments in INDsIIMPDs, CTAs, and BLAs/MAAs.
Participate, as needed, in planning, organizing and managing the CMC component of preIND meetings with FDA.
Experience and Required Skills:
I. The successful candidate's primary office location will be in Renssalaer, NY. 2. Masters degree in life science requiredl Doctoral degree in life science highly desirable 3. A minimum of 5 years of related experience in CMC regulatory, and/or process/analytical science in bio/pharmaceutical industry; experience in biologics required 4. Excellent writing skills / excellent organizational, attention to details, critical thinking required. Good presentation skills highly desirable. Must be facile with Microsoft Office.
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, disability status, protected veteran status, or any other characteristic protected by law.