Senior Manager – Regulatory Submission Compliance
Regeneron
full-time
Posted on:
Location Type: Hybrid
Location: Armonk • 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.
- Review clinical regulatory documentation submitted to global health authorities.
- Lead and coordinate the pre-submission review process.
- Participate in cross-functional meetings to identify CMC regulatory issues.
- Develop and improve procedures and systems for review and feedback.
- Lead meetings and presentations on complex regulatory issues.
- Provide CMC regulatory submission oversight of CRO activities.
- Implement comprehensive training, tools, and reporting metrics for senior management.
- Act as a submission compliance liaison with various departments.
- Mentor, coach, and manage direct reports to develop regulatory capabilities.
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)
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
regulatory submissionclinical regulatory documentationpre-submission reviewCMC regulatory oversightsubmission complianceprocedures developmentreporting metricstraining implementationmentoringcoaching
Soft Skills
leadershipcommunicationcross-functional collaborationproblem-solvingpresentation skillsorganizational skillsteam managementfeedback provisionmentorshipcoaching