Director CMC Regulatory Affairs

Leads the Chemistry, Manufacturing, and Controls (CMC) & Combination Products (CP) Internal Medicine team. The candidate will be responsible for the development and execution of global regulatory strategies for the assigned drug/device portfolio. This role involves overseeing regulatory affairs staff, various outside contractors, supporting project teams and development partners, and leading activities with the Health Authority.

A typical day might include:

- Oversee the assigned CMC/CP Regulatory Affairs team, driving global regulatory strategies and operational direction for the assigned portfolio, including initial clinical registrations, market application approvals, and post-approval lifecycle management.

- Lead the preparation, review, and submission of regulatory documents (e.g., meeting packages/briefing book, scientific advice, BLAs, MAAs, BPDRs, supplements) to regulatory authorities.

- Provide scientific and regulatory inputs for the assigned portfolio to facilitate and expedite the development and marketing of drugs and/or biologics.

- Oversee and direct interactions with global regulatory authorities, including meetings, information request responses, and inspections.

- Direct and give advice on compliance activities (e.g., change controls, deviations) for the assigned portfolio, evaluating regulatory impacts and associated submission requirements for clinical and commercial regulatory filings in accordance with country-specific guidelines.

- Develop and implement department objectives and work plans, delegate responsibility effectively, and prioritize team workloads to meet organizational goals.

- Provide leadership by contributing to departmental strategy, organizational goals, and policy development.

- Guide team members to address complex and unprecedented program challenges, ensuring timely resolution.

- Participate in cross-functional groups and working groups to improve current practices and establish new processes/procedures.

This Role Could Be a Great Fit If You Have:

- Proven track record of supporting biological products and/or small molecule drugs through development and approval is a distinct advantage.

- Strong understanding of current CMC / CP worldwide regulations.

- Successful leadership in delivering CMC/CP sections of marketing authorizations, clinical trial applications (CTA/IND), and post-approval submissions for biological products, combination products, and/or small molecule drugs.

- Previous experience with device regulatory requirements and development processes for combination products is an advantage.

- Human Factors experience is a plus.

- Experience in dealings with the FDA and other regulatory authorities.

- Experience managing and developing staff members.

In order to be considered for this role, you must have:

- A bachelor’s degree with a minimum of 10 years of pharmaceutical/biotech industry experience, including a minimum of 8 years of relevant CMC experience. Alternatively, a master’s degree with 8+ years of experience, or a PhD degree with 3+ years of experience.

- At least 3 years of applicable managerial experience.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other countries’ specific benefits, please speak to your recruiter.
Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron’s roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron’s on-site policy and expectations for your role and your location.

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)

$172,200.00 - $286,900.00

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