Director, CMC Regulatory Affairs

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Job description

Leads the Chemistry, Manufacturing, and Controls (CMC) non-antibody team for cell and gene therapy technologies. The candidate will be responsible for assuring development and execution of global regulatory strategies for assigned cell and gene therapy portfolios. This role includes overseeing regulatory affairs staff, various outside contractors, supporting project teams and development partners and leading Health Authority activities.

In this role, a typical day might include:

• Direct activities of assigned Regulatory Affairs team with emphasis on global regulatory strategy and the preparation, review, and submission of documents for FDA, EMA and other regulatory authorities.

• Establish operational objectives and work plans and appropriately delegate to team setting the priority for the workload

• Provide leadership with input about departmental strategy, organizational goals, and current policies

• Provide and drive strategic and operational global CMC regulatory direction and documentation for portfolio of CGT products covering clinical studies, initial registrations and approval/post approval activities.

• Provide guidance and directions to unit members to facilitate them addressing complex and unprecedented program issues in a timely manner

• Provide high-level strategy input on critical regulatory filing documents (e.g., meeting packages/briefing books, scientific advice, BLAs, MAAs, BPDRs, supplements) to facilitate and expedite the development, licensure, and marketing of CGT drugs and/or biologics. Perform final review and approval for all global submissions for the portfolio to ensure alignment with program regulatory strategy and development plan.

• Provide oversight for interactions with global regulatory authorities (e.g., meetings, IR responses, inspections).

This role might be for you if you have:

• Proven track record of supporting cell and gene therapy products through development and approval is a distinct advantage

• Needs to have good understanding of current CMC worldwide regulations for CGT products

• Successful leadership in delivering CMC sections of marketing authorizations, clinical trial applications (CTA/IND) and post-approval submissions for biologic products / combination products and gene therapies

• Experience in dealings with FDA, EMA or other regulatory authorities

• Experience managing and developing staff members essential

To be considered for this opportunity you must have:

• Bachelors degree in a relevant technical, scientific discipline required; advanced degree strongly preferred

• A minimum of 10 years pharmaceutical/biotech industry experience including a minimum of 5 years of relevant CMC Regulatory experience including experience in the field of cell and gene therapies or masters degree with 8+ or PhD with 3+ years working.

• 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 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)

$176,900.00 - $294,800.00

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