Senior Director, Regulatory Clinical Strategy

Senior Director, Regulatory Clinical Strategy at Kaye/Bassman International Senior Director, Regulatory Clinical Strategy at Kaye/Bassman International in Mountain Lakes, New Jersey Posted in about 21 hours ago.

Type:

full-time

Job Description:

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.