Senior Manager – Regulatory Submission Compliance
Regeneron
full-time
Posted on:
Location Type: Office
Location: Tarrytown • New Jersey • New York • United States
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Salary
💰 $134,400 - $219,200 per year
Job Level
About the role
- 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.
Requirements
- 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.
Benefits
- 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
- paid leaves (e.g., military and parental leave) for eligible employees at all levels!
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
regulatory submission managementCMC regulatory documentationclinical regulatory documentation reviewsubmission complianceproject managementprocedures developmentreporting metricstraining implementationoversight of CRO activitiesregulatory justifications
Soft Skills
communicationleadershipmentoringcoachingcross-functional collaborationproblem-solvingstrategic planningorganizational skillspresentation skillsvisibility improvement