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Zevra Therapeutics · 1 day ago

Vice President, Head of Regulatory Affairs

Boston, MA

Full-time

Onsite

Director/Executive

15+ years exp

Zevra Therapeutics is a rare disease therapeutics company focused on making life-changing therapeutics available to patients. The VP, Head of Regulatory Affairs will lead global regulatory strategy and execution across the company's portfolio while fostering professional growth within the team and improving internal processes.

BiotechnologyPharmaceuticalTherapeutics

Responsibilities

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

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

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

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

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

Partner with QA on GxP compliance and inspection readiness

Own RA systems and documentation flows

Drive intelligence and policy monitoring

Advise Executive Team and Board on regulatory risk/mitigation

Ability to effectively communicate with internal costumers, third-party partners, and regulatory authorities

Represent the company externally at stakeholder meetings, conferences, and consortia

Qualification

Regulatory AffairsRare Disease ExpertiseUS/EU Regulatory StrategyLeadership in SubmissionsECTD ProficiencyCMC IntegrationPublic SpeakingTeam LeadershipCommunication Skills