Senior Manager Regulatory Affairs

Regulatory Connect; Boston (MA); Hybrid; USD 120,000 - 125,000; Full time

Job summary

A leading company is seeking a Senior Manager in Regulatory Affairs to lead global submission activities. This role involves managing vendors and ensuring compliance with health authority requirements. Ideal candidates will have significant experience in regulatory affairs and project management.

Qualifications

• Minimum 5 years in the pharmaceutical or biotech industry.
• 3+ years in regulatory affairs with IND/CTA/NDA/MAA experience.

Responsibilities

• Lead planning, preparation, and submission of regulatory dossiers.
• Provide regulatory guidance to cross-functional teams.
• Manage responses to health authority queries.

Skills

Project Management

Communication

Interpersonal Skills

Organizational Skills

Education

Bachelor’s degree

Advanced degree in a scientific field

Tools

Regulatory Publishing Tools

Document Management Systems

Job description

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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.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Science

• Industries

  Pharmaceutical Manufacturing and Biotechnology Research

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