Exelixis · 1 day ago
CMC Regulatory Dossier Management Director
Alameda, CA
Full-time
Onsite
Director/Executive
$192K/yr - $272K/yr
10+ years expExelixis is a company focused on providing PSC Regulatory expertise and leadership for biologics and Bioconjugates commercial and development projects. This role is responsible for leading the development of high-quality regulatory submissions and managing interactions with health authorities, while ensuring compliance with regulations and overseeing cross-functional collaborations.
BiotechnologyHealth CarePharmaceutical
Responsibilities
Lead development of high quality, phase appropriate CMC-related submissions to regulatory authorities and regulatory affairs. Tracks progress of authoring, reviewing, approving and submitting to publishing, including submissions across multiple countries and clinical studies
Lead development of responses to health authority questions and documentation requests
Ensure appropriate archiving of source technical documentation
Lead review of chemistry, manufacturing, and controls-related documentation (e.g., INDs, IMPDs, NDAs, BLAs) with SMEs, CDMOs and Exelixis leadership. May be required to provide relevant content or develop documents and templates as necessary
Track and manage external partner regulatory actions, documentation associated with regulatory actions in both post-approval and development stage changes through completion
Liaise internally with Regulatory Affairs CMC to coordinate CMC changes with other aspects of the development programs
Ensure continued regulatory compliance and phase appropriate, risk-based approaches to manufacturing flexibility while adhering to change control procedures and health authority requirements
Monitor Biologics CMC regulations and guidance to assess relevant changes and implications to current and future development and commercial activities
Contribute to the implementation of processes and procedures, including developing and authoring internal work instructions and company SOPs
Work with cross-functional teams to identify and support continuous improvement opportunities for processes and systems
Provide strategic and forward-looking guidance regarding processes and systems surrounding review committees
People management responsibility and oversight (through direct reports and as an individual contributor as needed) within Bio CMC and cross-functionally
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
Lead internal preparation of CMC strategy in support of any required meetings with Regulatory Agencies and/or RFIs (Request for Information) from health authorities, including preparation of supporting documentation, as necessary
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
Minimum sixteen years pharmaceutical industry and/or regulatory agency experience or the equivalent combination of experience and education/training
Minimum ten years regulatory experience in a position of substantial responsibility
Experience with Biologics and ADCs
Prior experience working with Health Authorities and/or review divisions at FDA required
Demonstrated knowledge of US and international regulatory requirements pertinent to this role
Uses broad expertise or unique knowledge and skills to contribute to development of company objectives and principles and to achieve goals in creative and effective ways
Develops technical and/or business solutions to complex problems
Exercises problem solving, strategic thinking skills with ability to impact and influence
Guides the successful completion of major programs, projects and/or functions
Interprets, executes, and recommends modifications to departmental and cross-functional processes and standards
Leads or manage the work of others by providing guidance to subordinates or teams based on organizational goals and company policy, with responsibility for results, including costs, methods, and staffing
Performs a variety of complicated tasks with a wide degree of creativity and latitude
Responsible for maintaining a working knowledge of regulatory requirements and guidelines and for communicating changes in regulatory information to departmental and team colleagues
Has good general knowledge of other related disciplines
Applies strong analytical and business communication skills
Preferred
Experience in oncology
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
Company data provided by crunchbase