The Opportunity: Regulatory Affairs DirectorAs Regulatory Affairs Director, you will play a critical leadership role in translating our global regulatory strategy into execution across programs, regions, and service lines.
You will oversee a portfolio of regulatory activities, ensuring high-quality, compliant, and timely delivery while leading and developing a team of Regulatory Affairs professionals. You'll work closely with cross-functional teams and act as a senior point of contact for both internal stakeholders and external partners.
This role sits at the intersection of
strategy, delivery, and leadership, and is key to scaling our Regulatory Affairs capabilities globally.
Geographic Requirement: To ensure seamless collaboration with our teams, applicants
must reside within the EST or CST time zones.
What you'll do in this role:Drive regulatory strategy execution- Translate company and RA/PV strategy into clear regulatory plans across programs and regions
- Drive implementation across Expanded Access Programs (EAPs), Clinical Trials, and Real-World Data initiatives
Oversee program and portfolio delivery- Oversee multiple regulatory programs simultaneously, ensuring delivery against timelines, quality standards, and client expectations
- Identify and proactively manage cross-program risks, dependencies, and resource constraints
Lead and develop the team- Lead, coach, and develop Regulatory Affairs Managers and senior team members
- Set clear expectations and drive accountability for performance, quality, and delivery
Collaborate cross-functionally- Partner closely with Program Management, Medical Affairs, Quality Assurance, and Supply Chain
- Ensure regulatory input is embedded into end-to-end program delivery
Drive operational excellence and performance- Drive standardization, consistency, and scalability of regulatory processes
- Identify improvement opportunities and implement data-driven solutions
Engage with clients and stakeholders- Act as a senior point of contact for clients on regulatory matters
- Support client discussions, audits, and regulatory interactions with Health Authorities
Ensure quality, compliance, and risk management- Ensure adherence to global regulatory requirements and internal processes
- Support inspection readiness and audit preparedness
What you bring to the table:- Advanced degree in life sciences, pharmacy, or a related field
- Significant experience in Regulatory Affairs within pharma, biotech, or CRO environments
- Proven experience managing multiple programs and complex regulatory portfolios
- Strong knowledge of global regulatory frameworks (EAP, clinical trials, or similar environments)
- Demonstrated leadership experience managing teams and developing talent
- Excellent stakeholder management and communication skills
