Senior Manager – Regulatory Submission Compliance

Regeneron Pharmaceuticals • Warren, MI

8d • Onsite

About The Position

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.

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.

Responsibilities

• 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.

Benefits

• comprehensive benefits, which vary by location
• 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)

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Number of Employees: 5,001-10,000 employees