Senior Manager – Regulatory Submission Compliance

Role Overview

• 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!