Regulatory Affairs CMC Director

Exelixis • Alameda, CA

20h

About The Position

SUMMARY/JOB PURPOSE: Provide Regulatory Affairs CMC expertise and leadership for global commercial and development projects. Develop strategic approaches to enable succesful 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 for global applications (INDs, IMPDs, NDAs, BLAs, MAAs). 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 CMC-related submissions to Health Authorities and provide regulatory guidance to PSC. Ensure submissions to regulatory Health Authorities are complete, of high quality, and compliant with applicable regional regulations while enabling appropriate CMC flexibility. Work with teams to develop responses to review questions from FDA and other regulatory authorities. Track progress of submission review and approval stages across multiple clinical studies and countries. Lead any required CMC-related meetings with Health Authorities working closely with PSC. Provide briefing book templates, collaborate with PSC on meeting prep sessions, and manage the live meeting with the Health Authority. Track and manage through completion Health Authority facing regulatory actions and commitments throughout the product life cycle. Facilitate transition of core Module 3 documents to regional formats for submission Ex-US. Liaise 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 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. People management responsibility and oversight (through direct reports and/or as an individual contributor) of other compliance-related initiatives within Regulatory and cross-functionally. Provide leadership within the Regulatory department, including 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

Requirements

• 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.
• 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, 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 CMC-related submissions to Health Authorities and provide regulatory guidance to PSC.
• Ensure submissions to regulatory Health Authorities are complete, of high quality, and compliant with applicable regional regulations while enabling appropriate CMC flexibility.
• Work with teams to develop responses to review questions from FDA and other regulatory authorities.
• Track progress of submission review and approval stages across multiple clinical studies and countries.
• Lead any required CMC-related meetings with Health Authorities working closely with PSC.
• Provide briefing book templates, collaborate with PSC on meeting prep sessions, and manage the live meeting with the Health Authority.
• Track and manage through completion Health Authority facing regulatory actions and commitments throughout the product life cycle.
• Facilitate transition of core Module 3 documents to regional formats for submission Ex-US.
• Liaise 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 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.
• People management responsibility and oversight (through direct reports and/or as an individual contributor) of other compliance-related initiatives within Regulatory and cross-functionally.
• Provide leadership within the Regulatory department, including 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.

Benefits

• 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
• Number of Employees: 1,001-5,000 employees