Temp - CMC Regulatory Affairs Manager

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, atopic dermatitis, asthma, COPD, chronic rhinosinusitis with nasal polyps (CRSwNP), eosinophilic esophagitis (EoE), oncology, hypercholesterolemia, and rare inflammatory conditions.

Regeneron also has product candidates in development in other areas of high unmet medical need.

CMC Regulatory Affairs Manager - R50287 Location Warren or remote in the US Position Description At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases.

We are seeking a Temporary-Manager, CMC Regulatory Affairs, to join our Global Regulatory Affairs organization in Warren in an on-site or remote work model.

In this role, you will help shape regulatory compliance and strategy for biologic and combination products across the assigned portfolio, while collaborating with cross-functional IOPS teams.

This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

Roles Responsibilities

• Support CMC/Combination product development activities from a regulatory standpoint during early phase, development, submissions and post market requirements.
• Perform the compliance activities of the portfolio to determine regulatory impact and associated submission requirement for clinical and commercial regulatory filings. Assist specialists and colleagues in regulatory assessment of compliance tasks.
• Review the content and format of regulatory filing documents ensuring compliance with applicable regulations and guidelines governing the development, licensure, and marketing of drugs and/or biologics.
• Participate in global RA meetings and help to develop regulatory strategies. Participate in communications between Global RA and IOPS as needed.
• Support preparations for interactions with global regulatory authorities (e.g., meetings, IR responses).
• Develop and create Working Instructions, SOPs, and/or Reviewer’s Guide to facilitate consistent and efficient practice across the CMC/CP RA units.
• Identify gaps in the IOPS and global RA processes, raise to higher management, help to improve business efficiency.
• Participate in IOPS cross-functional meetings for program-specific discussions, connect the dots across IOPS, proactively identify CMC/CP regulatory issues and suggest appropriate strategies to mitigate or fix them, translates ambiguity into actionable steps. Ensure appropriate communications between IOPS and global RA in a timely manner.
• Contribute to the CMC/CP RA group development (e.g., discussion, presentation, generation of deliverables for training programs).

• Bachelor's degree with a minimum of 6 years of relevant pharmaceutical/biotech industry experience, or an advanced degree with 3 years of experience, including 2-4 years of relevant worldwide CMC regulatory affairs experience.
• Combination products is a plus.
• Experience delivering CMC sections of marketing authorizations, clinical trial applications (CTA/IND), and post-approval submissions for biologic products or combination products is an advantage.
• Experience interacting with FDA or other regulatory health authorities is an advantage.

• Bachelor's degree or advanced degree in a relevant field. This is a contract position at Regeneron in partnership with Agileone and Allsource as the Employer of Record. 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. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.