The Senior Manager— CMC Regulatory Submission Compliance is responsible for aligning the regulatory landscape with country-specific requirements and supporting clinical regulatory submission activities, supply planning, and QP certification. This role leads processes and cross-functional coordination, ensuring high-quality documentation and timely approvals for clinical and commercial activities.
A Typical Day:
Provide support for the management of the regulatory submission form process, reviewing clinical regulatory documentation submitted to global health authorities to enable lot release for clinical trials and commercial markets.
Lead and coordinate the pre-submission review process to ensure CMC regulatory documentation aligns with global requirements and country-specific expectations.
Participate in cross-functional meetings to identify CMC regulatory issues related to submission documentation; ensure clear communication between IOPS and global development on submission-related risks.
Develop and improve procedures and systems for review and feedback on the CMC global clinical regulatory submission packages, approvals, and status updates to improve visibility and efficiency.
Lead meetings and presentations on complex regulatory issues; contribute to and build regulatory justifications to support filings.
Provide CMC regulatory submission oversight of CRO activities, ensuring deliverables meet compliance standards and timelines.
Keep management and collaborators advised of assessments, overall strategy, and project status through structured reporting and updates.
Implement comprehensive training, tools, and reporting metrics for senior management to strengthen submission compliance and operational readiness.
Act as a submission compliance liaison with Regulatory Affairs, Regulatory Submission Management, Clinical Drug Supply and Logistics, and Quality to ensure submissions appropriately support the release of investigational product.
Support activities by ensuring documentation completeness and compliance.
Mentor, coach, and, where applicable, manage direct reports to develop regulatory capabilities and consistent practices.
This Role Might Be for You If You Have:
A Bachelor’s degree in Chemistry, Biology, or a related field; advanced qualifications or program management experience are a plus.
8+ years of experience in the biotech or pharmaceutical industry, including a minimum of 2 years of relevant CMC 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.
