Job Description
Role Overview
We are representing our client in the search for a Vice President of Regulatory Affairs . Based in Boston, you will lead the regulatory function at the executive level, driving strategy for clinical development, marketing authorization, and lifecycle management of pharmaceutical products.
You will provide strategic guidance to the Executive Board and serve as the company’s primary liaison with regulatory authorities, including FDA, EMA, and other international agencies. You will ensure regulatory considerations are embedded across R&D, Clinical, Quality, and Commercial teams to accelerate development timelines and enable successful product launches.
Key Responsibilities
- Regulatory Strategy & Leadership
- Define and implement regulatory strategies for global clinical development programs and product registrations.
- Advise the Executive Board on regulatory risks, opportunities, and compliance issues impacting development and commercialization.
- Align regulatory strategy with corporate and commercial objectives to maximize patient access.
- Regulatory Operations
- Lead submissions and approvals for INDs, NDAs/BLAs, clinical trial applications, variations, renewals, and post-approval commitments.
- Engage proactively with FDA, EMA, and other international health authorities to facilitate approvals and resolve regulatory challenges.
- Ensure regulatory compliance throughout the product lifecycle, including post-marketing obligations.
- Team Leadership & Development
- Build, lead, and mentor a high-performing regulatory affairs team with expertise across clinical, CMC, and lifecycle management.
- Drive cross-functional collaboration to ensure regulatory requirements are considered in early-stage development and commercialization planning.
- External Representation
- Represent the company in discussions with regulators, industry associations, and professional forums.
- Establish strategic relationships that enhance the company’s influence and credibility within the global regulatory landscape.
Candidate Profile
- Advanced degree in Life Sciences, Pharmacy, Medicine, or related discipline; PhD or MD preferred.
- 15+ years in regulatory affairs within the pharmaceutical industry, with at least 8 years in senior leadership roles.
- Deep experience with FDA, EMA, and other international regulatory frameworks.
- Proven track record of leading successful regulatory submissions and approvals across multiple therapeutic areas.
- Strong understanding of clinical development, CMC, and product lifecycle management.
- Exceptional leadership, strategic thinking, and stakeholder management skills.
- Fluent in English; additional language skills a plus.
- Experience managing remote or distributed teams is advantageous.
Job Tags
Remote work,