Associate Director, Global Regulatory Affairs
sotalentEast Boston (MA)
Associate Director, Global Regulatory Affairs
Posted 2 days ago
sotalentEast Boston (MA)
SENIORITY
Manager
About the role
Associate Director, Global Regulatory Affairs – Marketed Products Find out if this opportunity is a good fit by reading all of the information that follows below. Boston, Massachusetts | Hybrid Working Are you an experienced Regulatory Affairs professional looking to influence global regulatory strategy for innovative therapies that improve patients' lives around the world? An exciting opportunity has arisen for an Associate Director, Global Regulatory Affairs to join a leading global biopharmaceutical organisation committed to advancing transformative treatments across multiple therapeutic areas. This is a highly visible leadership role where you will partner with cross‐functional teams across R&D, clinical development, market access, and commercial functions to shape and execute global regulatory strategies for marketed products. You'll play a critical role in ensuring successful regulatory outcomes while helping bring life‐changing therapies to patients worldwide.
Key responsibilities include:
- Leading global regulatory strategies across complex and high‐profile product portfolios
- Acting as Global Regulatory Lead (GRL) and providing strategic guidance to cross‐functional project teams
- Leading Global Regulatory Teams and associated working groups to ensure alignment and successful execution of regulatory plans
- Managing regulatory submissions, approvals, lifecycle management activities, and post‐marketing regulatory strategies
- Serving as the primary contact for regulatory authorities, including direct interaction with the FDALeading and managing regulatory agency meetings and negotiations
- Identifying regulatory risks and developing proactive mitigation and contingency strategies
- Providing strategic regulatory advice to support business objectives and product lifecycle plans
- Collaborating closely with market access and health economics teams on value evidence and regulatory initiatives
- Supporting due diligence activities for licensing, acquisition, and business development opportunities
- Mentoring and supporting the development of junior regulatory professionals
- The successful candidate will possess:
- Significant pharmaceutical industry experience with a strong background in Regulatory Affairs
- Proven experience developing and executing global regulatory strategies
- Experience leading regulatory submissions and interactions with major health authorities, particularly the FDAStrong understanding of the drug development process and post‐marketing regulatory requirements
- Knowledge of US, European, Canadian, and international regulatory environments
- Excellent communication, stakeholder management, and leadership skills
- The ability to analyse complex scientific and regulatory information and translate it into strategic recommendations
This role would be particularly well suited to regulatory professionals who enjoy working in highly collaborative environments where they can influence decision‐making at both a strategic and operational level.
You'll be joining a globally respected organisation that is investing heavily in research, innovation, and the development of life‐changing therapies. The company is recognised for its collaborative culture, commitment to scientific excellence, and dedication to improving patient outcomes worldwide. xmcpwfu
In return, you'll benefit from a highly competitive compensation package, bonus potential, excellent healthcare and retirement benefits, generous paid time off, ongoing professional development opportunities, and the chance to work alongside some of the industry's leading scientific and regulatory experts.
Working Pattern: Hybrid
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