Associate Director, Global Regulatory Affairs

SoTalent; Boston (MA); Hybrid; USD 130,000 - 180,000; Full time

Benefits offered by this job

Highly competitive compensation package

Bonus potential

Excellent healthcare and retirement benefits

Generous paid time off

Ongoing professional development opportunities

Job summary

SoTalent is seeking an Associate Director, Global Regulatory Affairs to influence global regulatory strategy for innovative therapies. This role is critical in shaping regulatory strategies and ensuring successful outcomes with cross-functional teams.

The successful candidate will have significant experience in Regulatory Affairs, strong leadership skills, and proven interactions with the FDA. You'll benefit from a competitive compensation package, bonus potential, and excellent healthcare benefits.

Qualifications

• 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 FDA.

Responsibilities

• Leading global regulatory strategies across complex product portfolios.
• Managing regulatory submissions, approvals, and lifecycle management activities.
• Serving as the primary contact for regulatory authorities, including direct interaction with the FDA.

Skills

Regulatory Affairs

Stakeholder management

Leadership

Communication skills

Regulatory strategy development

Job description

Associate Director, Global Regulatory Affairs – Marketed Products

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 FDA
• Leading 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 FDA
• Strong 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.

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