Associate Director CMC Regulatory Affairs

Regeneron Pharmaceuticals, Inc; Cambridge (MA); On-site; USD 154,000 - 253,000; Full time

Job summary

Regeneron Cell Medicine seeks an Associate Director in Regulatory CMC for biologics. This role involves developing regulatory strategies and ensuring high-quality submissions for cellular and gene therapy projects. The position emphasizes collaboration with internal teams and external partners, aiming to drive compliance and innovation in oncology projects.

Benefits

Health and wellness programs

Fitness centers

Equity awards

Annual bonuses

Paid time off

Qualifications

• 8+ years in pharmaceutical or biotech industry.
• 5+ years in Regulatory Science CMC for biologics.
• 3+ years in Cell & Gene Therapy products.

Responsibilities

• Oversees CMC regulatory submissions and interacts with regulatory authorities.
• Develops CMC regulatory strategies for oncology products.
• Collaborates with cross-functional teams to ensure compliance.

Skills

Organizational skills

Communication skills

Regulatory guidelines knowledge

Education

BS in life sciences

Masters or PhD preferred

Job description

Regeneron Cell Medicine is looking for an Associate Director in Regulatory CMC for biologics who will be responsible for the development and submission of regulatory filings for cellular & gene therapy projects (CAR T cell therapy) both in the US and internationally for our growing oncology franchise. In this position you will be responsible for driving the development of innovative CMC regulatory strategies and the preparation and submission of high‑quality CMC sections of INDs, CTAs, and original marketing applications (BLAs/MAAs), in close collaboration with our CMC and Quality teams, contract manufacturing organizations, external experts, collaborators, and global health authorities.

In this role, a typical day might include:

• Directs and oversees the preparation and review of high-quality CMC related regulatory submissions and leads the interactions and response to regulatory health authorities.
• Leads the development of global CMC regulatory science-based strategies for internal RCM oncology investigational products and/or in concert with external alliance partners.
• Effectively collaborates and communicate regulatory CMC strategy, risks, mitigations and regulatory filing plans to leadership and stakeholders as appropriate.
• Partner with cross functional CMC team SME members that may include, Development Manufacturing Supply and Quality (DMSQ), Regulatory Project Management & Program management, and external cross functional teams, Clinical, non-clinical and regulatory leadership.
• Drive adherence to relevant CMC regulatory guidelines relevant for internal and/or external development programs.
• Assess proposed manufacturing changes, provide strategic regulatory guidance to enable implementation and review and approve internal documentation to ensure conformance to regulations.
• Contribute to regulatory intelligence activities, monitor regulatory guidelines and provide interpretative guidance to CMC teams.

This role might be for you if you have:

• Proven track record of supporting cell and gene therapy products through development and approval, is preferred.
• Some antibody experience is a plus.
• Experience in expedited development and approval pathways.
• anizational and communication skills to provide clear direction to teams.
• Ability to manage technical SME’s to achieve alignment and progress to company and patient goals.
• Comprehensive knowledge of regulatory health authority guidelines (i.e., FDA, EMA, and ICH guidelines).

To be considered for this opportunity you must have:

• Minimum BS in life sciences in biochemistry, biology, or related pharmaceutical fields including biochemical engineering: Strong preference for Masters or PhD
• Typically requires 8+ years of experience in pharmaceutical or biotech industry with a minimum of 5 years of progressively responsible experience in Regulatory Science CMC for biologics and a minimum of 3 years’ experience in Cell & Gene Therapy products.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, 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. 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.

For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.

Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.

Salary Range (annually)

$154,800.00 - $252,800.00