Director, Regulatory Affairs Strategy in United States at Jobgether

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Director, Regulatory Affairs Strategy based in the United States.

This is a high-impact leadership role responsible for shaping and executing global regulatory strategies across late-stage clinical development programs in the rare disease space. You will act as a key regulatory authority for Phase 2 and Phase 3 programs, ensuring alignment across clinical, medical, CMC, and commercial functions. The role involves close interaction with global health authorities, including the FDA and EMA, to support critical milestones and regulatory submissions. You will guide teams through complex development and approval pathways, including pivotal trials and marketing applications. Operating in a fast-paced, mission-driven environment, you will influence strategic decisions that directly impact patient access to life-changing therapies. This position requires strong cross-functional leadership, regulatory depth, and the ability to balance scientific rigor with business objectives.

• Lead the development and execution of global regulatory strategies for Phase 2 and Phase 3 clinical development programs.
• Provide strategic regulatory guidance on clinical development plans, pivotal trial design, statistical considerations, and registration pathways.
• Identify regulatory risks and opportunities, developing mitigation strategies to support successful program outcomes.
• Lead preparation and execution of global health authority interactions, including FDA, EMA, and other agencies.
• Develop briefing documents, regulatory questions, meeting strategies, and response packages for agency engagements.
• Represent the organization in regulatory meetings and negotiations with global health authorities.
• Oversee preparation and submission of key regulatory filings, including INDs, CTAs, NDA/BLA/MAA submissions, DSURs, and orphan drug applications.
• Ensure regulatory submissions are compliant, scientifically robust, and aligned with global strategy.
• Collaborate cross-functionally with Clinical Development, CMC, Nonclinical, Medical Affairs, Biostatistics, and Commercial teams.
• Provide regulatory leadership in labeling strategy, commercialization planning, and portfolio development activities.
• Monitor evolving global regulatory landscapes and advise leadership on implications for development programs.
• Mentor and develop regulatory team members, contributing to overall organizational capability building.

• Bachelor’s degree in a scientific or related field; advanced degree (MS, PharmD, PhD, MD) strongly preferred.
• 10+ years of progressive regulatory affairs experience in pharmaceutical, biotechnology, or life sciences industries.
• Proven experience leading global regulatory strategy for Phase 2 and Phase 3 development programs.
• Strong track record of successful interactions with FDA, EMA, and other major global health authorities.
• Experience supporting or leading NDA, BLA, MAA, or equivalent marketing applications.
• Deep understanding of global regulatory frameworks, drug development processes, and clinical trial regulations.
• Experience in therapeutic areas such as rare disease, oncology, immunology, neuroscience, or metabolic disease is preferred.
• Strong strategic thinking, scientific acumen, and ability to translate regulatory requirements into actionable development strategies.
• Excellent communication, negotiation, and influencing skills with senior internal and external stakeholders.
• Demonstrated ability to manage complex regulatory challenges in fast-paced, global environments.
• Strong leadership and cross-functional collaboration capabilities.
• Highly organized with the ability to manage multiple priorities and deadlines effectively.
• Willingness and ability to engage in occasional travel and collaborate across global time zones.

• Competitive compensation package including base salary, bonus, and long-term incentives.
• Comprehensive health, dental, and vision insurance coverage.
• Retirement plan with employer match.
• Life insurance, disability coverage, and financial protection programs.
• Generous paid time off and well-being support programs.
• Opportunity to contribute to innovative therapies in rare disease development.
• Exposure to global regulatory strategy and high-impact decision-making.
• Collaborative, patient-focused, and science-driven work environment.