Senior Manager/Associate Director, Regulatory Operations

Role Summary

Senior Manager/Associate Director, Regulatory Operations responsible for leading planning, preparation, and execution of regulatory submissions to advance biologies, cell, and gene therapy programs. Provides strategic and operational leadership for global regulatory submission activities, ensuring compliance with electronic submission standards and cross-functional alignment to meet regulatory milestones.

Responsibilities

• Lead and oversee the preparation, formatting, publishing, and submission of regulatory documents for INDs, IMPDs, BLAs, MAAs, and amendments.
• Ensure submissions are fully compliant with FDA, EMA, Health Canada, and ICH electronic submission standards (eCTD).
• Provide oversight of regulatory publishing activities, including vendor management and internal coordination, to achieve on-time delivery.
• Establish and maintain submission trackers, dashboards, and metrics for organizational visibility and audit readiness.
• Provide high-level review of submission components (CMC, clinical, safety) for accuracy, consistency, and compliance.
• Drive best practices in document lifecycle management, including version control, archival, and audit preparedness.
• Serve as a subject matter expert, monitoring changes in regulatory requirements and proactively updating processes and systems.
• Partner with Regulatory Affairs, Clinical, CMC, Quality, and Medical Writing leadership to align submission strategies with development goals.
• Advise internal stakeholders on regulatory submission requirements, timelines, and risks.
• Lead collaboration with IT and external vendors to optimize submission platforms and tools, driving efficiency and compliance.
• Provide mentorship and guidance to junior Regulatory Operations staff.
• Manage vendor relationships to ensure quality and timeliness of outsourced publishing activities.
• Contribute to department planning, resource allocation, and process improvement initiatives.

Qualifications

• Bachelor‚Äôs degree in life sciences or related field required; advanced degree preferred.
• 7‚Äì10 years of experience in Regulatory Operations within the biotechnology or pharmaceutical industry, with increasing leadership responsibility.
• Proven expertise in global regulatory submission requirements, including FDA, EMA, Health Canada, and ICH guidelines.
• Demonstrated proficiency in eCTD publishing, electronic submission platforms, and regulatory information management systems (RIMS).
• Experience managing teams and/or vendors to deliver complex submissions on accelerated timelines.
• Strong organizational skills with the ability to prioritize and lead multiple projects simultaneously.
• Exceptional communication and influencing skills; able to effectively partner with cross-functional leaders and external stakeholders.

Skills

• Regulatory operations leadership
• Global submission management (FDA, EMA, Health Canada, ICH)
• eCTD publishing and regulatory information management systems
• Vendor management and cross-functional collaboration
• Project prioritization and multi-project leadership
• Strategic planning and process improvement

Education

• Bachelor‚Äôs degree in life sciences or related field; advanced degree preferred

Additional Requirements

• In-office work environment; ability to be available outside of regular hours for priority needs