Associate Director CMC Regulatory Sciences (Post-Approval Commercial Submissions)

Regeneron is seeking a highly motivated and experienced Associate Director of CMC Regulatory Sciences to join our global team. This role is pivotal in leading post-approval commercial and global lifecycle management activities for Regenerons portfolio of commercial products. The ideal candidate will have demonstrated leadership skills and the ability to direct a function effectively.

As an Associate Director of CMC Regulatory Sciences your remit will include the following:

• Leading and managing the global CMC Regulatory Sciences Post-Approval Commercial team, providing strategic direction and oversight

• Fostering a collaborative and innovative environment, encouraging team development and growth

• Building and leading relationships with partners, regulators, and internal/external organizations

• Establish key performance indicators and capacity of the team and manage resources across program portfolio according to business priority

• Supervising post-approval regulatory activities, including new registrations, variations, and renewals

• Interacting with regulatory authorities from US, Canada, and other international health agencies in support of CMC topics

• Providing updates and reports to senior leadership on regulatory status and progress

• Being accountable for the performance of the post-approval commercial team

• Leading all aspects of development and execution of CMC regulatory strategies for new and existing products

• Ensuring alignment of CMC regulatory strategies with overall business objectives

• Ensuring the accuracy, quality, and clarity of written technical information/communications and ensure compliance with global regulatory requirements and guidelines

• Monitoring changes in regulatory landscapes and industry trends and collaborate cross-functionally to drive improvements in the business

This role might be for you if:

• You demonstrate leadership experience, with the ability to direct a global function effectively

• You possess in-depth knowledge of global regulatory requirements and guidelines

• You display strong technical skills and understanding of biopharmaceutical manufacturing processes and controls

• You have strong strategic thinking and problem-solving skills

• You possess excellent communication and interpersonal skills

• You thrive in a multifaceted and fast-paced environment

To be considered for this opportunity you should have a BS/BA in Life Sciences or a related field and 10+ years of relevant work experience. Relevant experience may be substituted in lieu of educational requirement.

#LI-Onsite # #JOBSIEPR #IREADV

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.