Senior Manager Regulatory Affairs

Hybrid - Cambridge

We are seeking a Senior Manager RA to lead global regulatory submission activities across development programs. This strategic and hands-on role will be responsible for managing vendors and contributing to global RA strategy and ensuring timely, high-quality submissions in alignment with global health authority requirements. If you are looking for more Reg strategy or vendor management experience (Operations) then this could be a good fit.

Key Responsibilities:

• Lead planning, preparation, and submission of regulatory dossiers including INDs, CTAs, NDAs, and MAAs.
• Provide strategic leadership and support on regulatory submissions.
• Manage global regulatory timelines, and ensure compliant and efficient execution of regulatory activities across development stages and product lifecycles
• Provide regulatory guidance to cross-functional teams including clinical, nonclinical, CMC, and commercial stakeholders.
• Manage responses to health authority queries (e.g., FDA, EMA, MHRA, Health Canada, TGA).
• Coordinate regulatory timelines, document workflows, and maintain submission compliance.
• Serve as the primary liaison for internal teams, external vendors, and health authorities on regulatory operational matters.
• Administer the Regulatory Information Management system and support document control systems.
• Contribute to continuous process improvement within regulatory operations.

Qualifications:

• Bachelor’s degree required; advanced degree in a scientific field preferred.
• Minimum 5 years in the pharmaceutical or biotech industry, including 3+ years in regulatory affairs with direct IND/CTA/NDA/MAA experience.
• Strong knowledge of global regulatory requirements and electronic submission processes (e.g., eCTD).
• Proficiency with regulatory publishing tools and document management systems.
• Demonstrated project management skills and ability to thrive in a dynamic environment.
• Excellent communication, interpersonal, and organizational skills.