Fellow, CMC - Regulatory Affairs
Fellowship position to gain training and experience in regulatory aspects/requirements related to Chemistry, Manufacturing and Controls (CMC) in the biopharmaceutical field.
1. Understand the purpose and content of regulatory filings such as pre-INDs, INDs, IMPDs, BLAs, MAAs, annual reports, DSUR, amendments and supplements. Perform critical reviews of these documents/dossiers to ensure high quality regulatory submissions.
2. Understand the change control process and assess the impact of CMC changes to regulatory filings (INDs/IMPDs, CTAs and BLAs/MAAs), ultimately ensuring the changes are reported to competent health authorities in accordance with regulatory requirements.
3. Participate in CMC project team meetings and provide current regulatory requirements that pertain to stability studies and analytical characterization tests.
4.Track and complete CMC regulatory commitments for INDs/IMPDs, CTAs and BLAs/MAAs.
• Requires a Ph.D. degree in a scientific discipline. Post-doctoral experience is preferred.
• Good oral and written communication skills are essential.
Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels!
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.