Hybrid Position
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 regulatory strategies supporting multiple development programs across clinical and non-clinical disciplines. 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.
