Exelixis · 1 day ago
Regulatory Affairs CMC Director
Alameda, CA
Full-time
Hybrid
Director/Executive
$192K/yr - $272K/yr
8+ years expExelixis is a biotechnology company focused on innovative cancer therapies, and they are seeking a Regulatory Affairs CMC Director to provide expertise and leadership for global commercial and development projects. The role involves developing regulatory strategies, ensuring compliance with Health Authority submissions, and leading cross-functional teams throughout the product lifecycle.
BiotechnologyHealth CarePharmaceutical
Responsibilities
Provide regulatory strategies, appropriate for the stage of product development, to PSC designed to maximize chances of successful and expedient registration with appropriate levels of CMC efficiency and flexibility
Critically review CMC-related submissions to Health Authorities and provide regulatory guidance to PSC. Ensure submissions to regulatory Health Authorities are complete, of high quality, and compliant with applicable regional regulations while enabling appropriate CMC flexibility
Work with teams to develop responses to review questions from FDA and other regulatory authorities
Track progress of submission review and approval stages across multiple clinical studies and countries
Lead any required CMC-related meetings with Health Authorities working closely with PSC. Provide briefing book templates, collaborate with PSC on meeting prep sessions, and manage the live meeting with the Health Authority
Track and manage through completion Health Authority facing regulatory actions and commitments throughout the product life cycle
Facilitate transition of core Module 3 documents to regional formats for submission Ex-US
Liaise with other members of the Regulatory Affairs department to coordinate CMC changes with other aspects of the development programs
Maintain regulatory compliance through adherence to change control procedures and completion of regulatory impact assessments
Monitor CMC regulations and guidance to assess relevant changes and implications to current and future development and commercial activities
Contribute to the optimization and implementation of processes and procedures, including developing and authoring internal work instructions and company SOPs and identifying solutions for process optimization and efficiency commensurate with departmental and company growth
People management responsibility and oversight (through direct reports and/or as an individual contributor) of other compliance-related initiatives within Regulatory and cross-functionally
Provide leadership within the Regulatory department, including identifying and managing through completion, departmental and cross-project initiatives and regulatory obligations
Liaise internally with members of Exelixis’ functional departments
Liaise externally with vendors, partners, and joint development collaborators
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, analyzing 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
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
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
Company data provided by crunchbase