Senior Regulatory Strategy Director (Remote)

Facet Life Sciences; United States; On-site; USD 180,000 - 300,000; Full time

Benefits offered by this job

Health insurance

Dental insurance

Life insurance

Disability insurance (short/long-term)

401K program

Annual training support

Flexible work environment

Unlimited sick and vacation

Job summary

Facet Life Sciences is seeking a senior leader to anchor and grow its Clinical Regulatory Affairs practice. This Director/AVP-level role will lead clinical and regulatory strategy for multiple client programs, guiding development from early stages through FDA milestones.

You will partner with biotech and pharma leadership, author critical submission documents, and shape Facet’s systems and capabilities while presenting strategies to boards.

Qualifications

• MD/PhD/PharmD or equivalent advanced degree preferred; other advanced degree considered with exceptional development background.
• 8–20 years of experience in pharma/biotech/medical device or life sciences consulting.
• Consulting experience required with senior client interaction and hands-on deliverable ownership.
• Proven track record leading regulatory strategy and submissions across drugs, biologics, devices, or combos.
• History of successful FDA interactions and leadership from early development through milestones.
• Experience creating innovative regulatory strategies amid scientific ambiguity.

Responsibilities

• Provide scientific leadership and clinical-regulatory strategy across client programs and therapeutic areas.
• Design and execute US regulatory and clinical development strategies for investigational and approved products.
• Interpret clinical data to inform regulatory strategy, submissions, and development pathways.
• Advise on IND, NDA, BLA, IDE, 510(k), De Novo, and other submissions with consistent messaging.
• Develop strategy for FDA meetings and expedited programs, including Fast Track and Breakthrough pathways.
• Synthesize research across areas and translate findings into executive summaries and client-ready recommendations.
• Lead cross-functional teams and mentor colleagues while maintaining timelines and budgets.

Skills

Regulatory strategy

Clinical development leadership

Executive communication

Cross-functional collaboration

FDA meetings

Education

MD/PhD preferred; MS or MBA with exceptional background may be considered

Job description

Facet Life Sciences is seeking a senior leader to anchor and grow its Clinical Regulatory Affairs practice. This Director/AVP-level role will lead clinical and regulatory strategy for multiple client programs, guiding development from early stages through FDA milestones.

You will partner with biotech and pharma leadership, author critical submission documents, and shape Facet’s systems and capabilities while presenting strategies to boards.