My client is a clinical-stage biopharmaceutical company focused on the discovery and development of innovative treatments for rare diseases. They have retained our firm to find a Vice President Global Regulatory Affairs to lead the development, planning, and execution of regulatory strategy and help achieve the company’s objectives. In this role, you will build the regulatory team and infrastructure needed to support their growing pipeline. This is an exciting time to join this growing organization and help get innovative programs approved!
- Serve as the company’s primary contact with FDA and other regulatory agencies as needed.
- Provide regulatory guidance and strategy including identifying and assessing regulatory risks for non-clinical, clinical and CMC activities
- Define strategy, required content and review of scientifically sound, accurate and complete non-clinical, clinical and CMC submissions to regulatory authorities including FDA, EMA and other national authorities to support the conduct of clinical trials and approval of marketing applications (IND, CTA, BLA/NDA, MAA, etc.)
- Oversee compilation, electronic processing and publishing to ensure high quality electronic submissions compliant with regulatory authority requirements.
- Maintain knowledge and monitor changes in new legislation and regulatory guidance. Interpret external developments and provide guidance to internal stakeholders.
- Works cross-functionally with internal departments, including clinical, manufacturing, and third parties on Regulatory Affairs related issues.
- Support development and presentation of development strategies for all development projects, and provide leadership on project teams in all areas of regulatory affairs
- Monitor, analyze, and disseminate intelligence on regulatory matters that may affect ongoing development programs
- Oversee the preparation of meeting requests and briefing documents, and plan, execute and lead the coordination and preparation of teams for health authority meetings
- Oversee the maintenance and creation of relevant SOPs, Work Instructions and other necessary guidance.
- Manage, train and mentor regulatory affairs personnel
- PhD with focus in Pharmaceutical Sciences or a technical field along with 10+ years of experience in Regulatory Affairs or BS/MS with 15+ years of relevant experience
- Proven experience in preparing strategies for and submitting marketing applications for pharmaceutical/biotechnology products (INDs, NDAs, MAAs)
- Expedited approval pathway or rare disease experience preferred
- Comprehensive knowledge and interpretive understanding of global regulations and guidelines (nonclinical, clinical and CMC).
- Experience in the preparation and submission of regulatory documents
- Experience in leading a team to prepare for major health authority interactions (e.g. FDA pre-NDA/BLA, EOP2 meetings, advisory committee meetings and/or EU oral explanations/scientific advice, etc.)
- Excellent interpersonal, oral, and written communication skills including presentation skills
- Demonstrated ability to work in a dynamic environment with a high degree of flexibility
- Demonstrated ability to work in a cross functional team and influence the decisions of a team
- Proven ability to meet aggressive time frames
- Ability to successfully prioritize competing and voluminous work streams simultaneously
- Highest ethical standards, integrity, credibility and character