Executive Director, Clinical Regulatory

Summary

This leadership role is responsible for developing and implementing global regulatory strategies for clinical investigational studies and commercialization of vaccines for both adult and pediatric populations. In collaboration with Clinical Development and Safety, the role provides regulatory guidance that enables and facilitates the preparation of clinical development protocols, interpretation and summary of clinical results, initiation, development and preparation of clinical and pre‑clinical regulatory documents, correspondence and responses to regulatory authorities toward commercial regulatory approval of novel vaccine products.

• Develop and execute globally viable clinical regulatory strategies.
• Develop, author and review regulatory CMC documentation for submission including application documents, correspondence and responses to queries. This includes requests for scientific advice in EU, Switzerland, UK and Canada, etc.
• Provide regulatory guidance for L2, L3 and L4 cross functional development teams.
• Ensure adherence to current regulatory requirements and alignment with appropriate regulatory guidance (including ICH) and industry best practices.
• Serve as a primary point of contact with regulatory authorities, i.e., FDA, EMA, MHRA, PMDA, Health Canada, etc., as appropriate.
• Contribute to the development of product label claims and justifications for clinical outcomes.
• Lead interactions and negotiations with global regulatory authorities for reconciliation of specific clinical and pre‑clinical issues to expedite regulatory application submissions and approvals.
• Support regulatory requirements for safety/pharmacovigilance notifications to regulatory authorities.
• Provide guidance on contemporary regulatory intelligence, statutory legislation and changes in regulatory authority requirements and expectations.
• Manage cross‑functional teams to demonstrate and ensure regulatory compliance.
• Optionally, people development and management may be expected.

• BA or BS in a relevant scientific or technical discipline, i.e., clinical pharmacology, immunology, biology, medicine, bioanalytics or related life sciences, with 15+ years industry experience that demonstrates technical and regulatory expertise and competence. Graduate education and/or professional certifications or training in regulatory and/or quality are a bonus.
• 10+ years of extensive and relevant regulatory experience with a proven record of achievement in developing and prosecuting regulatory submissions and application approvals within the pharmaceutical or biotechnology industry with a particular emphasis on vaccines and clinical content.
• A thorough understanding of clinical development, statistics with particular experience with vaccine development and commercialization.
• Direct experience engaging multiple health authorities, i.e., FDA, EMA, MHRA, Health Canada, etc., and preparation of regulatory applications for global health authorities.
• Demonstrated ability to lead and manage cross‑functional teams, developing and establishing regulatory strategies and preparing regulatory applications including review and submission of clinical and pre‑clinical documentation to regulatory authorities.
• Direct experience developing clinical regulatory strategies and submissions to effectively manage labelling for global markets and post‑approval changes and optimizations for commercial vaccines.
• Demonstrated record identifying clinical and regulatory risks and developing strategies and/or contingencies for mitigation.
• Experience translating and integrating contemporary regulatory intelligence into appropriate internal policies and practice.

Reports to: SVP, Regulatory Affairs

Location: Remote - US

Compensation: The compensation package will be competitive and includes comprehensive benefits and an equity component.

Salary Range: $299,000 - $349,000 (SF Bay Area). Salary ranges for non‑California locations may vary.

Relocation: This role is not eligible for relocation assistance.

We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.