Director Regulatory Strategy

The Director, Regulatory Strategy provides global regulatory leadership and strategic direction across one or more development programs in immunology. This role is accountable for shaping and executing regulatory strategies that enable timely product development, approval, and lifecycle management while ensuring compliance with global regulatory requirements. The Director acts as a strategic partner to R&D, Clinical, Quality, CMC, Commercial, and represents the organization in high‑level interactions with global regulatory authorities. 

 

Key Responsibilities 

Regulatory Strategy & Leadership 

• Develop and lead global, integrated regulatory strategies for investigational and marketed products across the product lifecycle, including late stage development. 

• Provide strategic input on development plans, target product profiles, labeling, indications, and sequencing of regulatory submissions. 

• Anticipate and mitigate regulatory risks; proactively identify opportunities for regulatory flexibility, expedited programs, and innovative pathways. 

• Serve as a key regulatory advisor to senior leadership and cross‑functional governance bodies. 

 

Regulatory Agency Engagement 

• Lead and/or oversee global regulatory authority interactions, including IND/CTA meetings, End‑of‑Phase meetings, scientific advice, and other milestone interactions. 

• Develop briefing documents, talking points, and negotiation strategies aligned with program objectives. 

• Interpret and communicate regulatory feedback to cross‑functional teams and translate it into actionable plans. 

Submissions & Execution Oversight 

• Provide strategic oversight for major regulatory filings (e.g., INDs/CTAs, NDAs/BLAs/MAAs, supplements, variations). 

• Ensure submission strategies are aligned with global regulatory expectations and business priorities. 

• Review and approve regulatory strategy documents, submission plans, and key content from a strategic perspective. 

Cross‑Functional Collaboration 

• Partner closely with Clinical Development, Biostatistics, CMC, Nonclinical, Pharmacovigilance, Quality, and Commercial teams to align regulatory strategy with development and commercialization goals. 

• Influence program decision‑making by integrating regulatory considerations early and consistently. 

• Support due diligence, licensing, and business development activities from a regulatory standpoint. 

People & Matrix Leadership 

• Mentor and develop regulatory strategists and/or regulatory leads; provide strategic oversight within a matrixed team environment. 

• Contribute to the evolution of regulatory strategy capabilities, processes, and best practices within the organization. 

• Promote a culture of scientific rigor, regulatory excellence, and proactive risk management. 

Policy & Intelligence 

• Monitor and interpret evolving global regulatory trends, guidance, and policy changes relevant to assigned programs or therapeutic areas. 

• Assess the impact of regulatory intelligence on development and lifecycle strategy. 

 

Required Qualifications 

• Bachelor’s degree required; Relevant advanced degree preferred (PhD, PharmD, MD, MSc, or equivalent in life sciences). 
• 7+ years of progressively responsible experience in Regulatory Affairs within the pharmaceutical industry. 
• Demonstrated experience leading global regulatory strategies for development programs and/or major regulatory submissions. 

• Proven success in direct interactions with global regulatory authorities. 

• Experience working in matrixed, cross‑functional development teams. 
• • Remote role; occasional travel required for regulatory meetings and internal governance forums. 

Skills & Competencies 

• Strong strategic thinking with the ability to balance regulatory risk, scientific evidence, and business objectives. 

• Deep understanding of global regulatory frameworks and product development. 

• Excellent leadership, influence, and communication skills, including the ability to engage senior executives. 

• Ability to navigate ambiguity and drive alignment across diverse stakeholders. 

• Strong written and verbal communication skills. 

 

Preferred Qualifications 

• Experience in a specific therapeutic area is a plus (e.g.,rare disease, immunology, neurology). 

• Experience with accelerated pathways (e.g., Fast Track, Breakthrough Therapy). 

• Experience supporting global commercialization and post‑approval lifecycle activities.