CMC Regulatory Affairs Fellow

Rensselaer, New York, US
Nov 13, 2018
Required Education
Position Type
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, and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including oncology, rheumatoid arthritis, asthma, atopic dermatitis, pain, and infectious diseases. Summary . Play a role of an intern in the CMC Regulatory Affairs department and be trained with various aspects of CMC Regulatory Affairs job functions. Essential Duties and Responsibilities include, but are not limited to, the following . Be trained with the critical reviews of pre-INDs, INDs, IMPDs, BLAs, MAAs, annual reports, DSUR, amendments and supplements to ensure high quality regulatory submissions and subsequent approvals . Be trained with the assessment of Change Controls by cross-checking the description in regulatory filings for INDs/IMPDs, CTAs and BLAs/MAAs, and ensure that CMC related changes are reported to competent health authorities in accordance with regulatory requirements . Be trained with the tracking and/or completing CMC regulatory commitments for INDs/IMPDs, CTAs and BLAs/MAAs . Participate in CMC project team meetings and provide current regulatory requirements that pertain to stability studies and analytical characterization tests . Education and Experience . Requires a Ph. D. degree in a scientific discipline e.g , Biochemistry, Protein Chemistry or a related field. Post-doctoral experience is required . Good oral and written communication skills are essential. 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.