Regulatory Affairs Strategy Manager (Oncology)
Exelixis
June 29, 2026
Remote friendly (Alameda, CA)
United States
$124,500 - $177,000 USD yearly
Corporate Functions
Summary/Job Purpose:
Responsible for managing and maintaining existing IND, CTA, NDA, and BLA submissions and preparing amendments in compliance with guidelines and regulations. Coordinates, compiles, and tracks product applications and submissions to regulatory agencies. Assists senior regulatory leaders with documents for designations, health authority programs/requirements, responses, and global regulatory planning.
Responsibilities:
- Review clinical site regulatory documents to provide approval to ship investigational product.
- Track safety reports and coordinate submissions to US INDs.
- Assist with preparing routine IND, NDA, BLA submissions and ex-US clinical trial applications; track submission progress and archive submissions/correspondence.
- Develop and implement strategies to ensure compliance with HA requirements.
- Respond to regulatory bodies’ requests for information.
- Serve as liaison with FDA.
- Work with consultants/contractors to complete regulatory activities and submissions.
- Contribute to department initiatives.
Qualifications (Education/Experience):
- Bachelor’s degree + 7+ years related experience; or Master’s + 5+ years; or PhD; or equivalent combination.
Required/Preferred Skills:
- Independently and collaboratively deliver quality work on established timelines.
- Apply regulatory knowledge to routine work.
- Clear verbal and written communication; timely updates to management/colleagues.
- Strong interpersonal skills; resolve differing views.
- Analytical problem-solving aligned with organizational objectives; integrity and trust-building.
- Follow predefined procedures; prioritize; identify/escalate broader-impact issues; implement solutions.
Working Conditions:
- Travel ~10%.
Benefits (as stated):
- 401(k) with company contributions; medical/dental/vision; life/disability; flexible spending accounts; discretionary annual bonus (or sales incentive if applicable); company stock purchase; long-term incentives; vacation/holidays; sick days.
Responsible for managing and maintaining existing IND, CTA, NDA, and BLA submissions and preparing amendments in compliance with guidelines and regulations. Coordinates, compiles, and tracks product applications and submissions to regulatory agencies. Assists senior regulatory leaders with documents for designations, health authority programs/requirements, responses, and global regulatory planning.
Responsibilities:
- Review clinical site regulatory documents to provide approval to ship investigational product.
- Track safety reports and coordinate submissions to US INDs.
- Assist with preparing routine IND, NDA, BLA submissions and ex-US clinical trial applications; track submission progress and archive submissions/correspondence.
- Develop and implement strategies to ensure compliance with HA requirements.
- Respond to regulatory bodies’ requests for information.
- Serve as liaison with FDA.
- Work with consultants/contractors to complete regulatory activities and submissions.
- Contribute to department initiatives.
Qualifications (Education/Experience):
- Bachelor’s degree + 7+ years related experience; or Master’s + 5+ years; or PhD; or equivalent combination.
Required/Preferred Skills:
- Independently and collaboratively deliver quality work on established timelines.
- Apply regulatory knowledge to routine work.
- Clear verbal and written communication; timely updates to management/colleagues.
- Strong interpersonal skills; resolve differing views.
- Analytical problem-solving aligned with organizational objectives; integrity and trust-building.
- Follow predefined procedures; prioritize; identify/escalate broader-impact issues; implement solutions.
Working Conditions:
- Travel ~10%.
Benefits (as stated):
- 401(k) with company contributions; medical/dental/vision; life/disability; flexible spending accounts; discretionary annual bonus (or sales incentive if applicable); company stock purchase; long-term incentives; vacation/holidays; sick days.