[Hiring] Senior Regulatory Operations Manager @Exelixis

Role Description

Manage and independently execute regulatory submission planning, publishing, quality control, delivery, archiving and lifecycle management for clinical and commercial programs. Provide eCTD technical expertise and manage submission plans in Veeva RIM to ensure timely, high-quality submissions that meet Health Authority requirements and company standards. Implement evolving FDA requirements and collaborate on process, technology and automation improvements to enhance efficiency, compliance and scalability.

• Independently format, publish, transmit and archive Health Authority submission types, ensuring submissions are high quality, compliant and delivered according to established timelines.
• Serve as subject matter expert for regulatory publishing and document management technologies such as LORENZ docubridge, Veeva Vault RIM, Microsoft Word, Adobe Acrobat and regulatory validation tools, as applicable.
• Provide Regulatory Operations expertise and guidance on eCTD structure, content readiness, publishing requirements, validation, dispatch and lifecycle management in accordance with Health Authority requirements.
• Perform document- and submission-level technical quality control to ensure completeness, consistency, accuracy and compliance with company standards and regulatory requirements.
• Identify IT solutions to enhance Regulatory Operations capabilities in document formatting and submission publishing, automation opportunities and technology enhancements that improve submission quality, efficiency, compliance and scalability.
• Create regulatory submission objectives, submission content plans, and documentation within Veeva RIM.
• Routinely participate in the review of evolving FDA electronic submission requirements and technical standards, assess operational impact and implement changes as appropriate.
• Collaborate within Regulatory Operations on SOPs, work instructions, templates, checklists, standards and best practices that support consistent and efficient Regulatory Operations processes.
• Performs other duties as assigned.
• Complies with all policies and standards.

Qualifications

• Bachelor’s degree in related discipline and a minimum of nine years of related experience; or,
• Master’s degree in related discipline and a minimum of seven years of related experience; or,
• PhD degree in related discipline and a minimum of two years of related experience; or,
• Equivalent combination of education and experience.

• Subject matter expert for regulatory publishing and document management technologies such as LORENZ docubridge, Veeva Vault RIM, Microsoft Word, Adobe Acrobat and regulatory validation tools.
• Manages time and resources to complete tasks and achieve results within established timelines. Takes pride in delivering high quality work.
• Applies knowledge of the regulatory framework and industry practices to complete routine 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 small groups of departmental colleagues.
• Good interpersonal skills and emerging ability to accommodate differing views to support the development of an agreed upon resolution.
• Works collaboratively with team members to achieve common objectives. Engages internal stakeholders to establish collaborative relationships.
• Applies knowledge of organizational objectives and demonstrates skill and insight in gathering, analyzing and applying key information to solve problems.
• Leads self by managing and executing own work. Acts with integrity and builds trust with colleagues to contribute to accomplishing team objectives.

Requirements

• 20% Travel approximately 20%

Benefits

• Comprehensive employee benefits package, including a 401k plan with generous company contributions.
• Group medical, dental and vision coverage.
• Life and disability insurance.
• Flexible spending accounts.
• Discretionary annual bonus program, or if field sales staff, a sales-based incentive plan.
• Opportunity to purchase company stock and receive long-term incentives.
• 15 accrued vacation days in the first year.
• 17 paid holidays including a company-wide winter shutdown in December.
• Up to 10 sick days throughout the calendar year.

Company Description

Exelixis is an Equal Opportunity Employer. We are committed to fostering an inclusive environment where everyone can thrive. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy (including lactation, childbirth, or related medical conditions), sexual orientation, gender identity, age (40 and over), national origin or ancestry, citizenship or immigration status, physical or mental disability, genetic information (including testing and characteristics), veteran status, uniformed servicemember status, or any other characteristic protected by applicable federal, state, or local law.

We are also committed to providing reasonable accommodations to qualified individuals with disabilities, unless undue hardship and/or a direct threat to the health and/or safety of the individual or others would result.

If you have a disability and need an accommodation in relation to the recruiting process, please email us at: [email protected].

Exelixis is an E-Verify employer.