We expect the Manager, Regulatory Affairs CMC to join a growing team and provide support to interpret the current, approved and planned clinical regulatory landscape by contributing to the regulatory submission form process.

In this role, a typical day might include the following:

• Contributes to the management of the regulatory submission form process, which involves the review of submitted documentation to global health authorities to support the release of lots to clinical trials.
• Support cross-functional departments in understanding the current, approved regulatory landscape for all global CTAs
• Participate in cross-functional meetings to help identify CMC regulatory issues related to submission documentation for clinical trials. Ensure appropriate communication between IOPS and global development in a timely manner.
• Participates in the development of procedures and systems for enhanced tracking of global regulatory submission packages and approval status.
• Lead meetings and presentation on more complex regulatory issues and participates in creating regulatory justifications
• Keeps management and all partners up to date of assessments, overall strategy, and project status.
• Contribute to training programs, metrics, and invoice approvals
• May act as a submission compliance liaison with other areas of Regulatory Affairs, Regulatory Submission Management, Clinical Drug Supply and Logistics, and Quality to ensure the submissions appropriately support the release of IP

This role might be for you if:

• You have a strong understanding of quality principals in a regulated manufacturing environment.
• You bring strong communication and program management skills
• You can implement improvements to processes while having scope changes occur during the project.
• You are able to lead matrix environments and collaborate easily with colleagues

To be considered for the opportunity, we expect you to have at 5 years of experience in the life science industry with a focus in biopharmaceutical manufacturing or regulatory or compliance related activities with a Bachelor's degree in Chemistry, Bio or related field. We also expect individuals to have managed or lead teams for 2 years.

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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)

$104,300.00 - $170,100.00