Director, Regulatory Strategy

Responsible for driving the development and implementation of global regulatory strategies that align with asset and corporate goals as well as health authority requirements. Ensures timely preparation of organized, consistent, and scientifically valid submissions.

Requirements

• Interact directly with regulatory authorities.
• Conduct effective and timely regulatory intelligence and research.
• Represent Regulatory Affairs in multi-disciplinary teams to establish development and regulatory strategies for early and late-stage development programs.
• Oversee the preparation and completion of regulatory submissions.
• Contribute to the implementation of processes and procedures.
• Lead multiple assets and/or studies as assigned.
• Liaise internally with members of Exelixis’ functional departments.
• Liaise externally with vendors, licensors, consultants, 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
• 15 accrued vacation days in first year
• 17 paid holidays including a company-wide winter shutdown in December
• Up to 10 sick days throughout the calendar year