Senior Director, Regulatory Clinical Strategy

My client is a leading commercial-stage biopharmaceutical company focused on non-opioid pain management and regenerative health solutions, with a robust pipeline of small molecules, biologics, and gene therapies.

Position: The Senior Director, Regulatory Clinical Strategy, will lead the development and execution of global regulatory strategies supporting multiple development programs across clinical and non-clinical. This individual will serve as a strategic regulatory leader, partnering closely with cross-functional teams and senior leadership to support global development objectives and interactions with health authorities.

Responsibilities:

• Lead global regulatory strategy development for multiple and complex development programs spanning early development through post-marketing activities.
• Provide strategic regulatory guidance for INDs, CTAs, NDAs, BLAs, and interactions with global health authorities.
• Develop regulatory submission strategies, briefing materials, and communications with health authorities.
• Assess regulatory risks and provide strategic recommendations to advance the program.
• Support regulatory planning across clinical and non-clinical development activities.
• Guide cross-functional teams on regulatory pathways, development strategy, and submission planning.
• Remain current on evolving regulatory guidance, competitive intelligence, and industry trends that may impact development strategy.
• Partner closely with Clinical Development, Non-Clinical, CMC, Medical Affairs, Legal, and Commercial teams.
• Lead regulatory discussions with internal stakeholders and external regulatory agencies.
• Support project planning, prioritization, and execution to ensure key milestones are achieved.
• Influence strategic decision-making through effective communication and regulatory leadership.

Qualifications:

• Bachelor’s degree in Life Sciences or related field required; advanced degree preferred.
• 10+ years of progressive Regulatory Affairs, Clinical, and Non-Clinical experience within the pharmaceutical or biotechnology industry.
• Strong experience supporting global regulatory strategy across clinical and non-clinical development.
• Experience supporting regulatory submissions and interactions with FDA and other global health authorities.
• Demonstrated expertise in regulatory pathways, drug development strategy, and regulatory risk assessment.
• Strong understanding of non-clinical, clinical, and pharmaceutical development requirements.
• Ability to lead cross-functional initiatives within a matrixed environment.
• Excellent communication, presentation, and leadership skills.
• Strong analytical, strategic thinking, and problem-solving capabilities.
• Experience supporting complex development programs, including biologics, specialty pharmaceuticals, or innovative therapeutic platforms, is highly desirable.