Director, Global Regulatory Affairs New Remote with up to 20% domestic travel

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 Angitia Established in June 2018, Angitia Biopharmaceuticals is a clinical-stage biotechnology company focused on the discovery and development of innovative therapeutics for serious musculoskeletal diseases. Angitia 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, Angitia is committed to providing groundbreaking therapies to satisfy key unmet medical needs. The founder and the core team members of Angitia 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.

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

Voluntary Self-Identification

For government reporting purposes, we ask candidates to respond to the below self-identification survey.Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiringprocess or thereafter. Any information that you do provide will be recorded and maintained in aconfidential file.

As set forth in Angitia Incorporated Limited’s Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law.

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection.As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measurethe effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categoriesis as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.