Director, Global Regulatory Affairs

Position: Director, Global Regulatory Affairs

Department: Development - Regulatory Affairs

Location: U.S (Remote) with up to 20% domestic travel

Reports To: Executive Director, Global Regulatory Affairs

Position Summary

The Director, Global Regulatory Affairs is responsible for developing and executing global regulatory strategies for assigned development programs. The Global Regulatory Lead serves as the primary regulatory representative on cross-functional teams and provides strategic leadership across all phases of development, from early-stage programs through registration and lifecycle management.

The Director, Global Regulatory Affairs partners with Clinical Development, Nonclinical, CMC, Safety, Biostatistics, and Operations to align regulatory strategy with development and business objectives. The role represents the company in interactions with global health authorities and provides regulatory leadership and mentorship across project teams.

Responsibilities

• Lead the development and execution of global regulatory strategies for assigned development programs.
• Lead the products Global Regulatory Team and represent Regulatory Affairs on governance and cross-functional development teams.
• Provide regulatory leadership across nonclinical, clinical, CMC, registration, and lifecycle management activities.
• Partner with cross-functional teams to shape development plans, study designs, endpoints, and regulatory pathways.
• Identify regulatory risks and opportunities and develop appropriate mitigation and management recommendations.
• Lead regulatory strategy and execution for health authority interactions, including meeting preparation, briefing materials, and responses.
• Provide strategic oversight and direction of major regulatory submissions, including INDs, CTAs, amendments, and marketing applications.
• Direct global and regional submission strategies in partnership with regional regulatory stakeholders.
• Ensure regulatory submissions are scientifically sound, strategically aligned, and of high quality.
• Monitor evolving regulatory requirements and assess potential impact on development programs.
• Build and maintain effective relationships with regulatory authorities, consultants, contractors, and partners.
• Influence cross-functional teams to achieve program objectives while balancing regulatory and business considerations.
• Mentor junior regulatory professionals and contribute to departmental initiatives, process improvements, and capability development.
• Provide regulatory recommendations and strategic input to senior management and governance committees.
• Maintain a global perspective and promote alignment across programs, regions, and functional areas.

Qualifications

• Bachelor's degree in Life Sciences or related discipline; advanced degree preferred (PharmD, MS, PhD, MBA, or equivalent).
• 10+ years of pharmaceutical or biotechnology experience, including at least 8 years in Regulatory Affairs strategy.
• Significant experience supporting global development programs through registration and lifecycle management.
• Strong knowledge of regulatory requirements and frameworks in the US, EU, and Japan.
• Experience leading interactions with health authorities, including FDA, EMA, and PMDA.
• Experience developing major regulatory submissions and regulatory strategies.
• Experience in rare disease, orphan drug development, or other specialized development pathways is preferred but not required.
• Demonstrated ability to lead and influence cross-functional matrix teams.
• Strong strategic thinking, problem-solving, and decision-making skills.
• Excellent communication, presentation, and interpersonal skills.
• Strong organizational skills and ability to manage multiple priorities.
• Experience working in multinational and multicultural environments.

Salary Range : $180k - $230k

About the company

Established in June 2018, the company Biopharmaceuticals is a clinical-stage biotechnology company focused on the discovery and development of innovative therapeutics for serious musculoskeletal diseases. The company is currently studying 2 biologic product candidates in the clinic for the treatment of osteoporosis, and osteogenesis imperfecta (OI). Leveraging the team's extensive experience and scientific acumen in novel drug development, the company is committed to providing groundbreaking therapies to satisfy key unmet medical needs. The founder and the core team members of the company are seasoned scientific leaders in new drug discovery, development, and management from both overseas and domestic large multinational companies. The company has built its headquarters in Westlake Village, CA, USA, and offices in Guangzhou, China, which is distinguished by world-class scientists with talents that are proficient in the pathophysiology of musculoskeletal diseases. The company is committed to serving patients in need by carrying out innovative science, including internal research and external collaborations with academics and global biopharmaceutical companies. We are seeking talented individuals who are innovative, ambitious, and great team players to join our vibrant group.

Learn more at [link for members]

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
• Telecommunication Monthly Stipend
• Work-From-Home Equipment Reimbursement