The Associate Manager, CMC Regulatory Affairs will be responsible for developing and implementing regulatory strategies for biologic products for the portfolio assigned. They will be orchestrating CMC related strategies from pre-IND to post approval.
In this role, a typical day might include the following:
- Responsible for CMC product development activities from a regulatory standpoint during the entirety of the drug development process
- Provide regulatory interpretation, position and strategy for global CMC 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
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 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
To be considered, we are looking for applicants to have 3+ years of experience within Regulatory Affairs CMC with a focus on Biologics/Large Molecules. We also expect you to be in the office a couple days a week.
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 comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible 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 parental 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.The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.