Director Global Regulatory Lead
Director Global Regulatory Affairs
A global pharmaceutical organization is expanding its regulatory leadership team and seeking a Director, Global Regulatory Affairs to provide strategic oversight for global regulatory activities supporting one or more drug development programs. This role is responsible for shaping regulatory strategy across regions, guiding cross‑functional teams through critical regulatory milestones, and leading effective engagement with global health authorities from development through lifecycle management.
The position requires a strong balance of regulatory strategy, executional oversight, and cross‑functional influence within a global, matrixed environment.
Responsibilities
- Develop and maintain integrated global regulatory strategies aligned with overall development, clinical, and commercialization objectives
- The Director will be responsible for complex or highly complex or multiple projects; defines strategies and provides tactical guidance to teams and collaborates cross-functionally to ensure the global regulatory strategy is updated and executed
- Serve as the regulatory strategic lead for assigned programs spanning early development through late‑stage development and post‑approval lifecycle activities
- Lead the planning, preparation, and delivery of major global regulatory submissions, including INDs/CTAs, marketing applications, amendments, and post‑approval filings
- Act as the primary regulatory interface with global health authorities, driving meeting strategy, briefing package development, responses to questions, and regulatory negotiations
- Partner closely with Clinical Development, CMC, Nonclinical, Safety, Quality, Biostatistics, and Commercial teams to ensure cohesive regulatory planning and execution
- Lead the planning, preparation, and delivery of major global regulatory submissions, including INDs/CTAs, marketing applications, amendments, and post‑approval filings
- Act as the primary regulatory interface with global health authorities, driving meeting strategy, briefing package development, responses to questions, and regulatory negotiations
- Identify regulatory risks and opportunities early; develop mitigation strategies and provide clear regulatory guidance to program teams and leadership
- Ensure regulatory strategies remain current and responsive to evolving regulatory expectations, scientific data, and business priorities
- Coordinate with regional and local regulatory partners to support timely global filings and ensure ongoing compliance across markets
- Oversee external vendors and consultants supporting regulatory activities, ensuring quality, consistency, and adherence to timelines
- Support regulatory due diligence and strategic assessments for business development, licensing, or partnering opportunities
- Contribute to broader regulatory intelligence activities and internal process improvements as needed
- Provide functional leadership and mentorship to regulatory team members and matrix partners
- Influence decision‑making at the program and portfolio level through clear, data‑driven regulatory perspectives
- Communicate complex regulatory concepts effectively to both technical and non‑technical stakeholders
- Represent regulatory affairs in cross‑functional governance forums and strategic discussions
Qualifications
- Bachelor's degree in a scientific discipline required; advanced degree (MS, PharmD, PhD, MD) strongly preferred
- 8-12+ years of experience in regulatory affairs within the pharmaceutical or biotechnology industry
- Demonstrated experience developing and leading global regulatory strategies for drug development programs
- Direct experience with major health authority interactions and oversight of global regulatory submissions
- Strong understanding of global regulatory requirements and the drug development lifecycle
- Experience supporting complex or multiple concurrent development programs
- Exposure to accelerated development pathways and special regulatory designations
- Experience working across multiple global regions, including the US and international markets
- Prior experience contributing to regulatory strategy at a program or portfolio level
- Proven ability to operate independently, manage competing priorities, and lead through influence in a matrixed environment
- Excellent written and verbal communication skills, with strong strategic thinking and problem‑solving capability
FAQs
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