Assoc Regulatory Affairs CMC Director

Exelixis • Alameda, CA

19d • $166,000 - $236,500

About The Position

SUMMARY/JOB PURPOSE : Provide Regulatory Affairs CMC (RA CMC) expertise for global commercial and development projects. Develop strategic approaches to enable successful health authority submissions and communications. Work closely with the Pharmaceutical Operations and Supply Chain (PSC) organization, Quality groups, and cross-functional project teams on the CMC content of US investigational new drug applications (IND), ex-US clinical trial applications, and new drug applications (NDAs), and biologics license applications (BLAs). ESSENTIAL DUTIES/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 and provide regulatory guidance to PSC for CMC-related submissions to regulatory authorities. Help coordinate responses to questions from FDA and other health authorities. Ensure submissions to regulatory health authorities are complete, of high quality, and compliant with applicable regional regulations while ensuring future flexibility, in alignment with PSC Archive submissions and correspondence in the Veeva RIM system. Support cross-functional project teams on core Module 3 development, writing, and appropriate updates. Facilitate transition of core Module 3 documents to regional formats (e.g., IMPD, MAA). Track and manage through completion health authority facing regulatory actions occurring throughout the product life cycle. Liaise internally 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 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. 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. Liaise internally with members of Exelixis’ functional departments. Liaise externally with vendors, partners, and joint development collaborators.

Requirements

• 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.
• 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.
• 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.

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 and provide regulatory guidance to PSC for CMC-related submissions to regulatory authorities.
• Help coordinate responses to questions from FDA and other health authorities.
• Ensure submissions to regulatory health authorities are complete, of high quality, and compliant with applicable regional regulations while ensuring future flexibility, in alignment with PSC
• Archive submissions and correspondence in the Veeva RIM system.
• Support cross-functional project teams on core Module 3 development, writing, and appropriate updates.
• Facilitate transition of core Module 3 documents to regional formats (e.g., IMPD, MAA).
• Track and manage through completion health authority facing regulatory actions occurring throughout the product life cycle.
• Liaise internally 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 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.
• 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.
• Liaise internally with members of Exelixis’ functional departments.
• Liaise externally with vendors, partners, and joint development collaborators.

Benefits

• Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
• Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan.
• Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year.

What This Job Offers

• Job Type: Full-time
• Career Level: Director