Vice President, Head of Global Regulatory Strategy – Biologics / Rare Diseases

Location: Boston / Cambridge, Massachusetts
Working Arrangement: Hybrid | 2–3 Days On-Site Per Week
Employment: Full-Time | Permanent
Level: Vice President
Therapeutic Area: Rare Diseases / Neuromuscular Disorders / Biologics
Salary: $305,000–$360,000 Base
Travel: Approximately 20% | Domestic & International

Are you an experienced Global Regulatory Affairs leader with a strong background in biologics, rare diseases and global drug development? This is an exciting opportunity to join an innovative, growing biotechnology company developing next-generation monoclonal antibody therapeutics for patients with rare neuromuscular diseases and significant unmet medical needs.

We are seeking a strategic, hands-on VP, Head of Global Regulatory Strategy to build and lead a global regulatory strategy function, overseeing regulatory development, submissions and health authority engagement across an expanding therapeutic portfolio. The successful candidate will combine deep regulatory expertise with strong leadership capabilities, driving global regulatory strategies across clinical development, supplemental filings and lifecycle management while working closely with senior leadership and cross-functional development teams.

Key Responsibilities:

• Define and lead global regulatory strategies across clinical-stage and pipeline programmes, ensuring alignment with development and commercial objectives.

• Build, develop and lead a high-performing Global Regulatory Strategy team, providing strategic direction and regulatory expertise across the portfolio.

• Lead regulatory strategy for biologics and monoclonal antibody programmes, including subcutaneous formulation development and paediatric indications.

• Oversee global regulatory submissions, including supplemental applications, EU Type II variations and other post-approval regulatory filings.

• Lead interactions and negotiations with global health authorities, particularly the FDA and EMA, ensuring successful regulatory engagement.

• Develop comprehensive regulatory roadmaps, submission strategies and health authority engagement plans.

• Partner with Clinical Development, Medical Affairs, Market Access, CMC and Commercial teams to align regulatory strategies with programme objectives.

• Identify regulatory risks, assess emerging regulatory requirements and develop effective mitigation strategies.

• Provide strategic regulatory leadership across cross-functional programme teams, clinical development teams and governance committees.

• Ensure timely preparation, review and submission of high-quality regulatory documentation.

• Support regulatory activities relating to product lifecycle management, clinical labelling, business development and commercialisation.

• Represent regulatory strategy at senior leadership meetings, external regulatory interactions and strategic development discussions.

Candidate Requirements:

• Degree in Life Sciences or a related scientific discipline – essential.

• 15+ years of Regulatory Affairs experience within the biotechnology or pharmaceutical industry.

• Proven experience developing and leading global regulatory strategies – essential.

• Demonstrated experience leading successful FDA and EMA interactions – essential.

• Strong understanding of US and European regulatory requirements, global submission strategies and regulatory lifecycle management.

• Experience leading supplemental regulatory filings, sBLAs and/or EU Type II variations is highly desirable.

• Experience developing biologics, particularly monoclonal antibody therapeutics, is strongly preferred.

• Background in rare diseases, neuromuscular disorders or other specialised therapeutic areas is advantageous.

• Proven ability to build, develop and lead regulatory teams within a biotechnology or pharmaceutical organisation.

• Strong experience collaborating with Clinical Development, Medical Affairs, Market Access, CMC and Commercial functions.

• Excellent strategic leadership, communication, stakeholder management and problem-solving skills.

• Comfortable working in a fast-paced biotechnology environment with evolving priorities.

• Must be based in the Greater Boston area and able to work on-site in Cambridge 2–3 days per week.

• Willingness to undertake domestic and international travel as required, approximately 20%.

What's on Offer?

• $305,000–$360,000 base salary.

• Senior executive leadership opportunity within an innovative biotechnology company focused on rare diseases and next-generation biologics.

• Opportunity to build and lead the Global Regulatory Strategy function and influence regulatory decisions across a growing therapeutic portfolio.

• Significant involvement in global regulatory strategy, health authority interactions, supplemental filings and lifecycle management.

• Exposure to innovative monoclonal antibody therapies targeting rare neuromuscular conditions.

• Direct collaboration with senior executive leadership and multidisciplinary development teams.

• Hybrid working arrangement, with 2–3 days per week on-site in Cambridge, Massachusetts.

• Opportunity to play a key role in advancing potentially transformative therapies for patients with significant unmet medical needs.