Associate Regulatory Affairs Strategy Director (Oncology)
Exelixis
4 days ago
Remote friendly (Alameda, CA)
United States
Corporate Functions
Job Purpose:
Responsible for the development and implementation of global regulatory strategies aligned with asset and corporate goals and health authority requirements. Ensures timely preparation of organized, consistent, scientifically valid submissions. Translates regulatory requirements into practical, workable plans and communicates with stakeholders to reduce regulatory risk.
Responsibilities:
- Interact directly with regulatory authorities.
- Conduct regulatory intelligence and research; provide risk assessments and recommendations (including expedited pathways) to study and asset teams.
- Represent Regulatory Affairs on multidisciplinary teams to develop development and regulatory strategies for early and late-stage programs.
- Plan, review, prepare, submit, and maintain CTAs in Europe, Asia, and other regions with external vendors.
- Review clinical trial documentation (protocols, informed consents, clinical study reports) for regulatory compliance and alignment with objectives and strategy.
- Coordinate, author, and evaluate regulatory submissions to ensure completeness, organization, quality, appropriate messaging, and regional compliance.
- Oversee regulatory submissions (electronic and paper): INDs, supplements/amendments, IND safety reports, annual reports/DSURs, routine amendments, and NDA/BLA.
- Develop and author internal work instructions and company SOPs; contribute to process implementation.
- Lead multiple assets and/or studies as assigned.
- Liaise internally with functional departments; externally with vendors, licensors, consultants, and collaborators.
Qualifications:
- Bachelor’s (11+ years) or Master’s (9+ years) or PhD (5+ years) in a related discipline; or equivalent combination of education and experience.
Skills/Experience:
- Ability to manage multiple activities within timelines; deliver high-quality work.
- Broad knowledge of regulatory framework and industry practices; innovative approach to complex work.
- Strong verbal and written communication; effective presentation to groups.
- Strong interpersonal skills and ability to collaborate toward resolution.
- Experience managing teams and engaging stakeholders.
- Ability to gather/analyze/apply key information to solve problems.
Working Conditions:
- Travel approximately 10%.
Responsible for the development and implementation of global regulatory strategies aligned with asset and corporate goals and health authority requirements. Ensures timely preparation of organized, consistent, scientifically valid submissions. Translates regulatory requirements into practical, workable plans and communicates with stakeholders to reduce regulatory risk.
Responsibilities:
- Interact directly with regulatory authorities.
- Conduct regulatory intelligence and research; provide risk assessments and recommendations (including expedited pathways) to study and asset teams.
- Represent Regulatory Affairs on multidisciplinary teams to develop development and regulatory strategies for early and late-stage programs.
- Plan, review, prepare, submit, and maintain CTAs in Europe, Asia, and other regions with external vendors.
- Review clinical trial documentation (protocols, informed consents, clinical study reports) for regulatory compliance and alignment with objectives and strategy.
- Coordinate, author, and evaluate regulatory submissions to ensure completeness, organization, quality, appropriate messaging, and regional compliance.
- Oversee regulatory submissions (electronic and paper): INDs, supplements/amendments, IND safety reports, annual reports/DSURs, routine amendments, and NDA/BLA.
- Develop and author internal work instructions and company SOPs; contribute to process implementation.
- Lead multiple assets and/or studies as assigned.
- Liaise internally with functional departments; externally with vendors, licensors, consultants, and collaborators.
Qualifications:
- Bachelor’s (11+ years) or Master’s (9+ years) or PhD (5+ years) in a related discipline; or equivalent combination of education and experience.
Skills/Experience:
- Ability to manage multiple activities within timelines; deliver high-quality work.
- Broad knowledge of regulatory framework and industry practices; innovative approach to complex work.
- Strong verbal and written communication; effective presentation to groups.
- Strong interpersonal skills and ability to collaborate toward resolution.
- Experience managing teams and engaging stakeholders.
- Ability to gather/analyze/apply key information to solve problems.
Working Conditions:
- Travel approximately 10%.