Exelixis · 1 day ago
Director, Regulatory Strategy
Alameda, CA
Full-time
Onsite
Director/Executive
$204K/yr - $290K/yr
8+ years expExelixis is a company focused on developing innovative cancer therapies, and they are seeking a Director of Regulatory Strategy. This role is responsible for driving the development and implementation of global regulatory strategies that align with corporate goals and health authority requirements, ensuring timely and high-quality submissions to regulatory bodies.
BiotechnologyHealth CarePharmaceutical
Responsibilities
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
Coordinate, 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
Liaise internally with members of Exelixis’ functional departments
Liaise externally with vendors, licensors, consultants, and joint development collaborators
Directly supervise employees
Qualification
Required
Bachelor's degree in related discipline and a minimum of thirteen years of related experience; or
Master's degree in related discipline and a minimum of eleven years of related experience; or
PhD degree in related discipline and a minimum of eight years of related experience; or
Equivalent combination of education and experience
Develops and manages plans, establishes timelines, sets standards for performance
Proactively balances commitments and overcomes challenges to complete multiple activities and achieve results
Takes pride in delivering high quality work
Applies extensive knowledge of the regulatory framework, industry drivers and practices to develop innovative approaches and manage complex work
Demonstrates clear and effective verbal and written communication
Provides timely and appropriate information updates
Speaks clearly and confidently in one to one situations and effectively presents information to cross-functional groups of colleagues
Strong interpersonal skills and ability to accommodate differing views to influence an agreed upon resolution
Manages effectively performing teams, facilitates team alignment and achievement of common objectives
Engages internal and external stakeholders to establish productive collaborative relationships
Applies knowledge of organizational goals and objectives and demonstrates advanced skill and insight in gathering, analysing and applying key information to solve problems
Provides regulatory expertise to cross-functional teams
Understands longer term consequences of decisions and actions
Effectively leads and manages a team, acting with integrity to build trust and execute on team objectives that contribute to departmental goals
Capable of proactively assessing workload, trends, tasks and priorities for area of responsibility
Plans and executes multiple activities
Considers alternative methods and contingency plans to avoid potential issues
Designs and implements solutions to address project level challenges, taking into consideration the broader impact
Travel approximately 15%
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
2026-01-07
Investor's Business Daily
2025-12-22
2025-12-13
Company data provided by crunchbase