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 ophthalmology, hypercholesterolemia, oncology, rheumatoid arthritis, allergic asthma, and atopic dermatitis.
The Sr. Manager, CMC Regulatory Affairs will be responsible for developing and implementing regulatory strategies for biologic products and combination products for the portfolio assigned. They will be orchestrating CMC related strategies from pre-IND to post approval while also mentoring staff. With a range of products, there is plenty of experience to gain while working on novel compounds.
In this role, a typical day might include the following:
- Responsible for CMC/CP product development activities from a regulatory standpoint during the entirety of the drug development process
- Provide regulatory interpretation, position and strategy for global CMC/CP regulatory portfolios covering early phase, development, initial registrations and approval/post approval activities
- Seek out issues and develop regulatory strategies to mitigate risks
- Review and provide strategy input on filing documents (e.g. pre-INDs, INDs, IMPDs, BLAs, MAAs, BPDRs, annual reports, DSURs, amendments, supplements).
- Lead and facilitate activities, including team preparation, for meetings with FDA, EMA, etc. for CMC related matters
- Spearhead compliance activities of the portfolio to determine regulatory impact and submission requirement for regulatory filings in accordance with specific countries
This role might be for you if:
You have an understanding of CMC RA regulations.
You have a proven record of supporting biologics through development and approval
You have experience delivering CMC/CP sections of marketing authorizations, clinical trial applications (CTA/IND) and post-approval submissions for biologics / combination products
You have engaged with FDA and other regulatory authorities
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