Executive Director or Vice President, Regulatory Affairs

Direct Hire

Comp: 280k - 350k DOE

A senior leadership position requiring expertise in shaping regulatory approaches and fostering relationships with internal teams and global regulatory agencies (e.g., FDA, EMA). This role involves steering strategic initiatives, enhancing operational practices, and implementing essential policies. Additional responsibilities include overseeing clinical trial design, regulatory submissions, and team development, reporting directly to the organization’s top executive.

Primary Duties

• Develop and guide regulatory strategies for clinical development, with a focus on niche therapeutic areas.
• Partner with clinical teams to create and execute market readiness plans.
• Oversee preparation and submission of regulatory documents, including INDs and NDAs.
• Lead and mentor a high-performing regulatory team, establishing robust processes.
• Implement operational standards for submission procedures and internal compliance policies.

Ideal Candidate Profile

• Education and Experience:
• Background in Life Sciences with leadership in regulatory submissions for clinical programs.
• Significant experience (15+ years) in pharma or biotech, particularly involving advanced therapeutics.
• Expertise:
• Knowledge of the full product lifecycle, from trial design to market approval.
• Extensive familiarity with global regulatory frameworks and agencies.
• Proven ability to collaborate with cross-functional teams and external partners.
• Preferred Qualifications:
• Experience in rare disease and orphan drug development.
• A track record of successfully navigating regulatory discussions and submissions in multiple jurisdictions.
• Skills:
• Strong leadership, communication, and project management abilities.
• Ability to develop and execute both short- and long-term regulatory strategies.