Regulatory Affairs CMC Director

Provide Regulatory Affairs CMC expertise and leadership for global commercial and development projects. Develop strategic approaches to enable successful Health Authority submissions and communications.

Requirements

• 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.
• 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.
• 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

• 401k plan with generous company contributions
• Group medical, dental and vision coverage
• Life and disability insurance
• Flexible spending accounts
• Discretionary annual bonus program
• Sales-based incentive plan
• Opportunity to purchase company stock
• Long-term incentives
• Accrued vacation days
• Paid holidays
• Sick days