Director, Global Regulatory Lead
A leading global biopharmaceutical organization is seeking a Director, Global Regulatory Lead to provide strategic regulatory leadership across innovative programs within a growing therapeutic portfolio. This individual will drive global regulatory strategy, lead health authority interactions, and partner cross-functionally to advance products through development, approval, and lifecycle management.
Key Responsibilities:
- Develop and execute global regulatory strategies for complex development programs
- Lead regulatory activities across the product lifecycle, including early development, registration, and post-approval stages
- Serve as the regulatory representative on cross-functional program teams and provide strategic guidance to senior stakeholders
- Lead health authority interactions, including preparation and management of FDA meetings
- Oversee the planning, preparation, and submission of global regulatory applications and supporting documentation
- Identify regulatory risks and opportunities, developing mitigation strategies to support program objectives
- Collaborate with regional regulatory teams to ensure successful global implementation of regulatory strategies
- Contribute to business development activities, due diligence efforts, and cross-functional initiatives
- Mentor and develop regulatory professionals while fostering a collaborative team environment
Qualifications:
- Bachelor's degree in a scientific discipline required; advanced degree preferred
- 8+ years of pharmaceutical or biotechnology industry experience, including significant regulatory affairs experience
- Strong understanding of global drug development and regulatory requirements
- Experience developing and executing regulatory strategies for innovative therapies
- Proven track record leading major regulatory submissions and health authority interactions
- Ability to interpret complex scientific and clinical data and translate insights into regulatory strategy
- Excellent communication, leadership, and stakeholder management skills
- Experience working across global, matrixed organizations
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