Vp, Regulatory Operations Jobs

• Provide leadership and direction for all aspects of Regulatory Operations compliance i.e., submissions, document control, and regulatory archiving.
• Accountable for ensuring regulatory information management platforms comply with global and regional submission requirements.
• Responsible for professional development of direct and indirect reports within Regulatory Operations.
• Responsible for Regulatory Operations recruitment and hiring decisions.
• Lead and influence Regulatory Operations, [NR1] [SS2] through direct and indirect reports.
• Provide leadership to drive best practices and process improvements, including cross functional processes that involve Regulatory Operations.
• Develop and implement the optimum operating model for Regulatory Operations,
• Collaborate with R&D functional areas and provide expert advice on submission planning and execution in support of new and approved drug products.
• Develop global and regional procedures for all outsourced and in house regulatory operations in collaboration.
• Accountable for regulatory operations sourcing strategy, vendor management, and management of vendor costs

• Indirectly supervises employee(s) through a dotted line structure or via other subordinate supervisors.
• Directly supervises employees

• PhD degree in related discipline and a minimum of seventeen years of related experience; or,
• Bachelor’s degree in related discipline and a minimum of twenty-one years of related experience; or,
• Master’s degree in related discipline and a minimum of nineteen years of related experience; or,
• Equivalent combination of education and experience.

• Proven leader with a minimum of 15 years of pharmaceutical/biotech industry experience
• Possesses a track record of success in leading regulatory affairs activities across multiple phases of development with at least 12 years of regulatory experience in development programs

• Significant number of years successfully working with the FDA, utilizing novel regulatory pathways and applying creative approaches during negotiations
• Minimum of 5 years of recent oncology therapeutic area experience required
• Results oriented with strong initiative and accountability
• Deep knowledge and understanding of the drug development process and regulatory requirements and environment
• Strong leadership, verbal and written communication skills, and a demonstrated ability to develop constructive and effective relationships with direct reports, colleagues, and senior management
• Demonstrated strategic thinking ability and drive for successful regulatory outcomes
• Creative, analytical problem solver who acts decisively yet communicates the risks and benefits associated with all potential solutions so that informed business decisions can be made
• Strong interpersonal skills and the ability to manage, develop, and mentor personnel in a matrix environment skillfully and appropriately
• Proven ability to build and lead effective, well-integrated, collaborative teams and empower team members
• Experienced in the full range of regulatory submissions from IND to NDA and ex-US equivalents

• Environment: primarily working indoors
• Approximately 20% travel required

Our compensation reflects the cost of labor across several U.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this position is $316,750 - $368,250 annually. The base pay range may take into account the candidate’s geographic region, which will adjust the pay depending on the specific work location. The base pay offered will take into account the candidate’s geographic region, job-related knowledge, skills, experience and internal equity, among other factors.In addition to the base salary, as part of our Total Rewards program, 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.