Director of Global Regulatory Strategy
4 weeks ago
The Director of Global Regulatory Strategy will lead the development and implementation of global regulatory strategies to support the success of products throughout their lifecycle. This role will serve as the primary liaison to regulatory agencies and lead submission activities to regulatory agencies. The ideal candidate will have a strong working knowledge of relevant domestic and global regulations and guidance.
Key Responsibilities
- Develop and execute global regulatory strategies to support product success
- Prepare and/or supervise the preparation of regulatory submissions, including INDs, CTAs, GMOs, IDEs, amendments, annual reports, meeting briefing documents, responses to regulatory agency information requests, marketing authorization applications, and other regulatory submissions
- Serve as the primary liaison with FDA and other regulatory agencies throughout development of projects, including regulatory agency meetings and teleconferences
- Identify and assess existing and new regulations, guidance documents, international standards, or consensus standards, and provide interpretive guidance and ensure applicable implementation into development planning and execution
- Ensure that all regulatory activities and documents to be submitted to regulatory agencies have been evaluated to assure that they are complete, well organized, scientifically accurate, of high quality, and in regulatory compliance to facilitate agency review and acceptance
- Represent Global Regulatory Affairs as the primary contact on regulatory aspects of the projects and as a member of the cross-functional project team, providing regulatory guidance/strategy/perspective in team meetings and presentations at senior leadership governance meetings
- Oversee regulatory staff and participate in skill-development, coaching, and performance feedback of regulatory staff
- Manage vendors and/or clinical research organizations (CROs) performing regulatory activities on behalf of the company
- Participate in due diligence activities on potential licensing, acquisition, or collaboration opportunities
- Review and establish standard operating procedures (SOPs) and global regulatory affairs processes
Qualifications & Experience
- Bachelor's Degree
- At least 10 years of Global Regulatory Affairs experience
- Must have experience filing regulatory dossiers (CTAs, INDs, IMPDs)
- Track record of leading regulatory activities for development program
- Experience leading regulatory interactions including formal meetings
- Solid working knowledge of relevant domestic and global regulations and guidance
- Experience working in a matrix team environment
Desirable Qualifications
- Advanced degree (e.g., PhD, PharmD)
- Experience in cell and gene therapy and/or oncology is strongly preferred
- Experience with BLAs/NDAs/MAAs preferred
- Companion diagnostic experience (IDE, PMA/510K) desirable
- Experience managing staff
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