Director, Global Regulatory Affairs

This is a fully remote position, open to applicants in California.

📋 Description

• Guide the formulation and implementation of global regulatory strategies for designated development programs.

• Head the product's Global Regulatory Team and serve as the representative for Regulatory Affairs on governance and cross-functional development teams.

• Deliver regulatory leadership across nonclinical, clinical, CMC, registration, and lifecycle management activities.

• Collaborate with cross-functional teams to refine development plans, study designs, endpoints, and regulatory pathways.

• Recognize regulatory risks and opportunities, and formulate mitigation and management strategies.

• Oversee regulatory strategy and execution for interactions with health authorities, including preparation for meetings, briefing documentation, and responses.

• Provide strategic oversight and guidance for significant regulatory submissions, including INDs, CTAs, amendments, and marketing applications.

• Direct global and regional submission strategies in collaboration with regional regulatory stakeholders.

• Ensure that regulatory submissions are scientifically robust, strategically aligned, and of high quality.

• Keep abreast of evolving regulatory requirements and evaluate their implications for development programs.

• Cultivate and sustain relationships with regulatory authorities, consultants, contractors, and partners.

• Influence cross-functional teams to meet program objectives while balancing regulatory needs and business factors.

• Mentor junior regulatory professionals and contribute to departmental initiatives, process enhancements, and capability building.

• Offer regulatory insights and strategic guidance to senior management and governance committees.

• Maintain a global outlook and encourage alignment across programs, regions, and functional areas.

⛳️ Requirements

• Bachelor's degree in Life Sciences or a related field; an advanced degree is preferred (PharmD, MS, PhD, MBA, or equivalent).

• Over 10 years of experience in the pharmaceutical or biotechnology sector, with at least 8 years focused on Regulatory Affairs strategy.

• Extensive experience supporting global development programs through registration and lifecycle management.

• Deep understanding of regulatory requirements and frameworks in the US, EU, and Japan.

• Proven experience leading engagements with health authorities, including the FDA, EMA, and PMDA.

• Background in developing major regulatory submissions and crafting regulatory strategies.

• Experience in rare diseases, orphan drug development, or other specialized development pathways is advantageous but not mandatory.

• Demonstrated ability to lead and influence cross-functional matrix teams effectively.

• Strong strategic thinking, problem-solving, and decision-making abilities.

• Exceptional communication, presentation, and interpersonal skills.

• Excellent organizational skills with the capacity to manage multiple priorities.

• Experience working in multinational and multicultural environments.

🏝️ Benefits

• Medical, dental, and vision coverage for employees and their eligible dependents.

• 401(K) Retirement Plan with company match.

• Company-paid Long Term Disability coverage.

• Company-paid life insurance & AD&D coverage.

• Voluntary life insurance & AD&D coverage.

• Employee Assistance Program (EAP).

• Company-paid holidays.

• Vacation.

• Paid sick leave.

• Monthly stipend for telecommunication expenses.

• Reimbursement for work-from-home equipment.