Regulatory Affairs CMC Director

SUMMARY/JOB PURPOSE:

Provide CMC Regulatory expertise and leadership for commercial and development projects. Recognize the different 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. Manage a CMC team who manage relevant submissions to US investigational new drug applications (IND), ex-US clinical trial applications, and new drug applications (NDAs). Work closely with the Chemistry, Manufacturing and Controls (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).

• Review chemistry, manufacturing, and controls-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.

• 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) of other compliance-related initiatives within Regulatory 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.

• Provide leadership within the Regulatory department, 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.

SUPERVISORY RESPONSIBILITIES:

• None

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:

Education/Experience:

• 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.

Experience/The Ideal for Successful Entry into Job:

Knowledge/Skills:

• 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.

JOB COMPLEXITY:

• 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.

WORKING CONDITIONS:

• Travel approximately 15%

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