Associate Regulatory Affairs CMC Director

SUMMARY/JOB PURPOSE:

Ensure Exelixis development  and commercialized products are manufactured in accordance with approved chemistry, manufacturing and control (CMC) requirements. Provide CMC Regulatory expertise for commercial and development projects. Recognize requirements and restrictions for external data communication and presentation and represents the Regulatory considerations and point of view. Exercise strategic approaches for Health Authority filings and communications. Work closely with the PSC/CMC, Regulatory Affairs, and Quality Assurance departments, as well as with cross-functional project teams.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Coordinate CMC-related submissions to regulatory authorities and track progress of submission, review, and approval, including submissions across multiple countries and clinical studies. Help coordinate responses to questions. Ensure appropriate archiving of documentation.

• Support cross-functional project teams on core Module 3 development, writing, and appropriate updates. Facilitate transition of core Module 3 documents to regional format (e.g., IMPD, QOS).

• Prepare and review CMC related documentation (e.g., INDs, IMPDs, NDAs, BLAs) for compliance with regulatory guidance and as appropriate for the phase of development; may be required to provide relevant content or develop documents and templates, as necessary.

• Track and manage regulatory actions associated with post-approval and development stage changes through completion.

• Liaise internally with other members of the Regulatory Affairs department to coordinate CMC changes with other aspects of the development programs.

• Ensure continued 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 in 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.

• Liaise internally with members of Exelixis’ functional departments.

• Liaise externally with vendors, partners, and joint development collaborators.

SUPERVISORY RESPONSIBILITIES:

• None

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:

Education/Experience:

• Bachelor’s degree in related discipline and a minimum of eleven years of related experience; or,

• Master’s degree in related discipline and a minimum of nine years of related experience; or,

• PhD degree in related discipline and a minimum of five years of related experience; or,

• Equivalent combination of education and experience.

Experience/The Ideal for Successful Entry into Job:

Knowledge/Skills:

• Develops and manages plans within established timelines and balances commitments to complete multiple activities and achieve results. Takes pride in delivering high quality work.

• Applies wide knowledge of the regulatory framework and industry practices to develop innovative approaches and complete 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 groups of departmental colleagues.

• Strong interpersonal skills and ability to accommodate differing views to actively support the development of an agreed upon resolution.

• Manages effectively performing teams to achieve common objectives. Engages internal stakeholders to establish productive collaborative relationships.

• Applies knowledge of organizational goals and objectives and demonstrates skill and insight in gathering, analyzing and applying key information to solve problems.

• Leads self and others; acts with integrity and builds trust with colleagues to contribute to accomplishing team objectives.

JOB COMPLEXITY:

• Capable of managing the execution of multiple tasks.

• Ensures appropriate prioritization and execution for area of responsibility.

• Proactively anticipates, prioritizes and resolves task-related challenges.

• Designs and implements solutions to address task-related challenges, taking into consideration the broader impact.

WORKING CONDITIONS:

• Travel approximately 15%

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