Global Regulatory Strategy Director

Regulatory Jobs; Alameda (CA); Sur place; USD 248 000 - 353 000; Plein temps

Résumé du poste

Exelixis is seeking an experienced Regulatory Affairs leader to develop and implement global regulatory strategies that align with asset goals and health authority requirements. You will oversee submissions, coordinate cross-functional teams, and drive risk-based regulatory decisions.

You will direct interactions with authorities, manage CTAs and regulatory filings, and mentor a team to deliver high-quality documents on time while supporting strategic development programs across regions.

Qualifications

• Bachelor’s degree plus at least 15 years regulatory experience required.
• Master’s degree plus at least 13 years regulatory experience preferred.
• PhD plus at least 12 years regulatory experience required or equivalent.
• Equivalent combination of education and experience may be considered.

Responsabilités

• Interact directly with regulatory authorities.
• Conduct effective and timely regulatory intelligence and research to provide guidance to study and asset teams. Provide risk assessments and recommendations for various regulatory scenarios, including possible expedited pathways.
• Represent Regulatory Affairs in multi-disciplinary teams to establish development and regulatory strategies for early and late-stage development programs.
• Work with external vendors to plan, review, prepare, submit, and maintain CTAs in Europe, Asia, and other regions.
• Review clinical trial-related documentation (e.g., protocols, informed consents, clinical study reports) for compliance with regulatory guidance and alignment with study objectives and regulatory strategy.
• Lead, author and evaluate documents submitted to regulatory health authorities to ensure they are complete, organized, of high quality, contain appropriate messaging and compliant with applicable regional regulations.
• Oversee the preparation and completion of regulatory submissions (electronic and paper), including investigational new drug applications, supplements and amendments, IND safety reports, annual reports/DSURs, other routine amendments, and new drug applications (NDA)/biologics license applications (BLA).
• Contribute to the implementation of processes and procedures, including developing and authoring internal work instructions and company SOPs.
• Lead multiple assets and/or studies as assigned.

Connaissances

Regulatory strategy

Team leadership

Regulatory intelligence

Cross-functional

Attention to detail

Formation

Bachelor’s degree in related discipline and a minimum of fifteen years of related experience; or,

Master’s degree in related discipline and a minimum of thirteen years of related experience; or,

PhD degree in related discipline and a minimum of twelve years of related experience; or,

Equivalent combination of education and experience.

Description du poste

Exelixis is seeking an experienced Regulatory Affairs leader to develop and implement global regulatory strategies that align with asset goals and health authority requirements. You will oversee submissions, coordinate cross-functional teams, and drive risk-based regulatory decisions.

You will direct interactions with authorities, manage CTAs and regulatory filings, and mentor a team to deliver high-quality documents on time while supporting strategic development programs across regions.