Senior Manager – Regulatory Submission Compliance
Regeneron
9 hours ago
On-site
Sleepy Hollow, NY
Corporate Functions
Responsibilities:
- Support management of the regulatory submission form process by reviewing clinical regulatory documentation submitted to global health authorities to enable lot release for clinical trials and commercial markets.
- Lead and coordinate pre-submission review to ensure CMC regulatory documentation aligns with global requirements and country-specific expectations.
- Participate in cross-functional meetings to identify CMC regulatory issues; ensure clear communication between IOPS and global development on submission-related risks.
- Develop and improve procedures/systems for review and feedback on CMC global clinical regulatory submission packages, approvals, and status updates to improve visibility and efficiency.
- Lead meetings/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.
- Provide structured reporting and updates to keep management and collaborators informed of assessments, strategy, and project status.
- Implement training, tools, and reporting metrics 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 support release of investigational product.
- Ensure documentation completeness and compliance.
- Mentor, coach, and (where applicable) manage direct reports to develop regulatory capabilities and consistent practices.
Qualifications:
- Bachelor’s degree in Chemistry, Biology, or related field.
- 8+ years of experience in the biotech or pharmaceutical industry.
- Minimum 2 years of relevant CMC experience.
- Advanced qualifications or program management experience (plus).
Benefits:
- In the U.S., benefits may include health and wellness programs (medical, dental, vision, life, disability), fitness centers, 401(k) match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave).
Application instructions:
- Apply now.
- Support management of the regulatory submission form process by reviewing clinical regulatory documentation submitted to global health authorities to enable lot release for clinical trials and commercial markets.
- Lead and coordinate pre-submission review to ensure CMC regulatory documentation aligns with global requirements and country-specific expectations.
- Participate in cross-functional meetings to identify CMC regulatory issues; ensure clear communication between IOPS and global development on submission-related risks.
- Develop and improve procedures/systems for review and feedback on CMC global clinical regulatory submission packages, approvals, and status updates to improve visibility and efficiency.
- Lead meetings/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.
- Provide structured reporting and updates to keep management and collaborators informed of assessments, strategy, and project status.
- Implement training, tools, and reporting metrics 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 support release of investigational product.
- Ensure documentation completeness and compliance.
- Mentor, coach, and (where applicable) manage direct reports to develop regulatory capabilities and consistent practices.
Qualifications:
- Bachelor’s degree in Chemistry, Biology, or related field.
- 8+ years of experience in the biotech or pharmaceutical industry.
- Minimum 2 years of relevant CMC experience.
- Advanced qualifications or program management experience (plus).
Benefits:
- In the U.S., benefits may include health and wellness programs (medical, dental, vision, life, disability), fitness centers, 401(k) match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave).
Application instructions:
- Apply now.