Vice President, Head of Regulatory Affairs

Role Summary

The VP, Head of Regulatory Affairs is the company’s senior regulatory executive and a member of the leadership team. This leader owns the global regulatory strategy and execution across the portfolio consisting of commercial products and development assets. The VP of RA demonstrates exceptional leadership skills and a passion for fostering professional growth within their team as well as improving the internal processes in the department. The role blends strategic leadership with hands-on execution, suited to a lean organization.

Responsibilities

• Portfolio & Product Strategy
  • Define and continuously optimize global regulatory strategies (US/EU) for marketed and development programs.
  • Collaborate with internal customers, SMEs and other partners/stakeholders to ensure regulatory risk is factored in business plans and decisions.
  • Keep up-to-date and involved in the regulatory rare disease environment.
  • Lead informed go/no-go decisions cross-functionally.
• Submissions & Approvals
  • Own and direct major submissions and label negotiations.
  • Ensure inspection readiness and submission quality.
  • Prepare and lead Health Authority meetings and Advisory Committee meetings.
  • Hands-on execution of regulatory activities in cross-functional collaboration.
• Post-Approval & Lifecycle Management (Commercial Products)
  • Set and execute LCM roadmap.
  • Accountable for regulatory compliance activities to maintain Marketing Authorizations world-wide (periodic reporting, fee payment, safety reporting, promotional material etc.).
  • Support GxP compliance impacts on regulatory documentation, labeling and commitments.
• Development Programs (Clinical & CMC Integration)
  • Anticipate and steer expedited pathways and special designations.
  • Shape endpoints/COAs for rare diseases.
  • Drive CMC readiness for pivotal/registration.
  • Integrate patient voice and EAP/CUP considerations.
• Leadership & Organization
  • Build and develop a high-performing RA organization.
  • Foster talent development and mentorship to cultivate future regulatory leaders.
  • Establish operating rhythms and decision forums to ensure cross-functional communication, timely decision-making and tracking of progress.
  • Set and manage budgets and vendor strategy.
• Governance, Quality & Systems
  • Partner with QA on GxP compliance and inspection readiness.
  • Own RA systems and documentation flows.
  • Drive intelligence and policy monitoring.
• Enterprise Impact
  • Advise Executive Team and Board on regulatory risk/mitigation.
  • Ability to effectively communicate with internal customers, third-party partners, and regulatory authorities.
  • Represent the company externally at stakeholder meetings, conferences, and consortia.

Qualifications

• Required
  • Advanced scientific degree or equivalent experience.
  • 15+ years in Regulatory Affairs with significant rare-disease expertise.
  • Strong expertise in US/EU Regulatory Affairs in all drug stages from development to commercialization and experience with roll-out to global markets.
  • Demonstrated leadership of major submissions and successful HA engagements.
  • Hands-on experience integrating CMC, clinical, nonclinical evidence.
  • Strong team leadership in resource-constrained settings.
  • Proficiency with eCTD, RA publishing, and EDMS tools.
• Preferred
  • Experience with EAP/CUP, RWE strategies, COA/endpoint development.
  • Public speaking at AdComs or major scientific/regulatory forums.