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United States
Remote only
This position is listed on behalf of a partner company, which manages all applications and next steps. Our partner is looking for a Global Regulatory Strategy Director based in the United States.
As Global Regulatory Strategy Director, you will shape and lead regulatory strategies for an innovative pipeline of first-in-class small-molecule medicines. You will provide strategic regulatory leadership across clinical development, from Phase 2 through registration and lifecycle management. Acting as the regulatory subject matter expert, you will guide global project teams and lead interactions with health authorities worldwide. You will oversee the preparation and execution of critical regulatory submissions while identifying potential gaps and developing effective mitigation strategies. The role offers significant influence over global development and registration plans in a fast-moving, collaborative biotech environment. You will also lead and mentor regulatory colleagues while helping modernize regulatory operations and integrate AI into dossier development.
Provide regulatory leadership for clinical-stage assets through Phase 2 and subsequent development stages, establishing global regulatory and registrational strategies.
Independently develop and execute innovative regulatory strategies across the portfolio, including clinical development and product lifecycle management.
Lead the preparation, review, and submission of regulatory documentation, including INDs, CTx applications, briefing documents, Investigator's Brochures, NDAs, DMFs, IMPDs, and other required materials.
Identify regulatory submission gaps, assess potential risks, and develop practical mitigation strategies to support successful development and registration.
Represent the organization in interactions and negotiations with global health authorities, including the FDA, EMA, and Health Canada.
Serve as the Regulatory Affairs subject matter expert on cross-functional and global project teams, providing strategic guidance, oversight, and regulatory direction.
Ensure regulatory activities comply with applicable health authority requirements and coordinate reporting schedules with relevant cross-functional stakeholders.
Monitor changes in global regulatory requirements, emerging health authority initiatives, and industry developments, communicating their potential impact to senior leadership.
Lead and develop global regulatory teams, mentoring colleagues and supporting the growth and effectiveness of the Regulatory Affairs function.
Contribute to Regulatory Affairs leadership activities and provide strategic support to senior leadership as required.
Establish and maintain Regulatory Affairs policies, standard operating procedures, and work instructions.
Guide cross-functional teams in the adoption and implementation of AI-enabled approaches for regulatory dossier preparation and related activities.
Bachelor's degree in a scientific discipline; an advanced degree such as an MS, PharmD, or PhD is preferred.
At least 12 years of Regulatory Affairs experience within the pharmaceutical or biotechnology industry.
Broad regulatory experience across multiple stages of drug development, ideally spanning the full development lifecycle.
Proven ability to develop and execute global regulatory strategies for clinical-stage and commercial-stage programs.
Strong experience with oral small-molecule drug development and regulatory submissions ranging from IND/CTx applications through NDA or other marketing authorization applications.
Demonstrated experience negotiating and interacting with major global health authorities, particularly the FDA, EMA, and Health Canada.
Experience in obesity or dermatology programs is strongly preferred.
Excellent written, verbal, and presentation skills, including the ability to communicate complex regulatory matters and present strategic recommendations to senior leadership.
Strong cross-functional collaboration skills and the ability to represent Regulatory Affairs effectively within global project teams.
Solid understanding of regulatory operations, submission processes, and health authority reporting requirements.
Excellent organizational and planning capabilities, with the ability to manage multiple complex projects and competing deadlines in a fast-paced environment.
A proactive, independent, and entrepreneurial approach, with the flexibility to adapt to evolving priorities and business needs.
A pragmatic, solution-oriented mindset grounded in regulatory compliance and sound judgment.
Annual salary ranging from $220,000 to $250,000.
Medical, dental, and vision insurance, with 90% of coverage paid by the employer.
401(k) retirement plan with company matching.
Flexible paid time off.
A company-wide weeklong recharge break.
Adoption assistance.
Benefits available starting on the first day of employment.