Exelixis · 2 days ago
Regulatory Affairs Strategy Manager (Oncology)
Alameda, CA
Full-time
Onsite
Senior Level
$124K/yr - $177K/yr
5+ years expExelixis is a company focused on oncology, and they are seeking a Regulatory Affairs Strategy Manager to manage and maintain regulatory submissions related to drug applications. The role involves coordinating submissions, assisting with regulatory strategies, and serving as a liaison with the FDA.
BiotechnologyHealth CarePharmaceutical
Responsibilities
Review clinical site regulatory documents to provide Regulatory approval to ship investigational product
Track safety reports and coordinate submissions to US INDs
Assist Project Team Regulatory Representative in preparing routine IND, NDA and BLA submissions and ex-US clinical trial applications, tracking submission progress, and archiving regulatory submissions and correspondence
Assist with developing and implementing strategies to ensure compliance with HA requirements
Respond to requests for information from regulatory bodies
Serve as liaison with FDA
Work collaboratively with consultants and contractors to accomplish regulatory activities and submissions
Contribute to department initiatives
Qualification
Required
Bachelor's degree in related discipline and a minimum of seven years of related experience; or
Master's degree in related discipline and a minimum of five years of related experience; or
PhD degree in related discipline; or
Equivalent combination of education and experience
Works independently and with others to contribute to plans, complete tasks and achieve results within established timelines
Takes pride in delivering high quality work
Gathers, maintains and applies regulatory knowledge to complete routine work
Provides verbal and written communications that are clear and easy to understand
Provides timely and appropriate information updates to departmental management and colleagues
Good interpersonal skills, understanding of differing views; participates in reaching an agreed upon resolution
Works collaboratively with team members to achieve common objectives
Applies knowledge of organizational objectives and adopts an analytical approach to solve problems relevant to the role
Leads self by managing and executing own work, acts with integrity and builds trust with colleagues
Capable of following predefined procedures for specific tasks
Capable of identifying task-related challenges and prioritizing activity accordingly
Identifies and escalates issues that may have a broader impact
Implements solutions to address any task-related challenges
Benefits
401k plan with generous company contributions
Group medical, dental and vision coverage
Life and disability insurance
Flexible spending accounts
Discretionary annual bonus program
Sales-based incentive plan
Opportunity to purchase company stock
Receive long-term incentives
15 accrued vacation days in their first year
17 paid holidays including a company-wide winter shutdown in December
Up to 10 sick days throughout the calendar year
Company
Exelixis
Exelixis works is focused on discovering, developing and commercializing therapies for the treatment of cancer and other serious diseases.
1001-5000 employees
H1B Sponsorship
Exelixis has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (39)
2024 (25)
2023 (25)
2022 (28)
2021 (29)
2020 (15)
Funding
Current Stage
Public CompanyTotal Funding
$514MKey Investors
Deerfield
2015-07-23Post Ipo Equity· $135M
2012-02-16Post Ipo Equity· $65M
2010-06-03Post Ipo Debt· $160M
Leadership Team
Michael Morrissey
President and CEO
Christopher Senner
Executive Vice President and CFO
Recent News
The Motley Fool
2026-01-09
2026-01-08
Company data provided by crunchbase