CMC Regulatory Dossier Management Director

Role Summary

This role provides PSC Regulatory expertise and leadership for biologics and Bioconjugates commercial and development projects. Responsible and accountable for leading development of high-quality, phase appropriate regulatory sections and delivering documents to regulatory operations on aligned timeline. Responsible for developing strategy and supporting materials to support PSC related health authority interactions. Manages submissions to US investigational new drug applications (IND), ex-US clinical trial applications, and Biologics License Applications (BLAs) and ex-US license applications. This role works closely with the Bio CMC (Chemistry, Manufacturing and Controls (CMC)), Regulatory Affairs CMC and Quality Assurance departments, as well as with cross-functional project teams.

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‚Äô functional departments.
• Liaise externally with vendors, partners, and joint development collaborators.

Qualifications

• Bachelor‚Äôs degree in related discipline and a minimum of thirteen years of related experience; or
• Master‚Äôs 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.
• Experience in oncology preferred.

Skills

• 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.
• Environment: primarily working indoors.

Education

• No additional education details beyond those listed in Qualifications.

Additional Requirements

• None beyond inherent job requirements noted above.