Senior Director, Regulatory Affairs CMC

SUMMARY/JOB PURPOSE:

This role provides CMC Regulatory expertise and leadership for commercial and development projects. This role leads all regulatory activities related to chemistry, manufacturing, and controls (CMC) for each product development area from early development through to NDA/BLA. Provide the organization with the leadership and strategy to enable high quality and effective health authority and team communications to effectively drive development process. Manage Regulatory Affairs CMC staff for multiple product development programs, assign workload, and oversee CMC staff development.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Lead CMC regulatory activities for biologics/small molecules product development according to business priorities.

• In coordination with PSC/CMC leadership team, define and implement the global CMC strategy for early health authority interactions for IND/IMPD/NDA/BLA/MAA registrations.

• Manage all CMC-related submission activities and oversee timely delivery of high-quality technical documents including, briefing books, quality modules for clinical trial and marketing applications, drug master files, and responses to regulatory authority inquiries, while assuring all documents meet regulatory requirements and quality compliance.

• Serve as cross-functional leader and interact with colleagues in other departments, other R&D functions, and Regulatory Affairs functions to deliver high quality dossiers, documents and materials in accordance with business priorities.

• Provide regulatory leadership on technical and quality activities, such as manufacturing process development, specifications, in process controls, stability protocols, and change control management, and product and compliance quality initiatives.

• Work with internal teams and experts in CRO's for rest-of-world countries to develop regional CMC regulatory strategies.

• Provide leadership in the support of the regulatory documentation system(s) to reach excellence to ensure efficiency, traceability and compliance of regulatory CMC documents.

• Represent Regulatory Affairs CMC at health authority meetings and/or CMC-related conferences.

• Work with Regulatory Affairs Senior Management to identify resource needs, including consultants and new associates, advising on skills sets to meet needs.

SUPERVISORY RESPONSIBILITIES:

• Directly supervise and manage employees. Coach and mentor team members to provide regulatory advice to their cross-functional teams including requirements for product development and registrations.

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:

Education/Experience:

• Bachelor's degree in related discipline and a minimum of fifteen years of related experience; or,

• Master's degree in related discipline and a minimum of thirteen years of related experience; or,

• PhD degree in related discipline and a minimum of twelve years of related experience; or,

• Equivalent combination of education and experience.

Experience/The Ideal for Successful Entry into Job:

Knowledge/Skills:

• Develops and manages plans, establishes timelines, sets standards for performance. Manages and effectively communicates priorities. Motivates self and others to achieve business objectives and deliver results for areas of responsibility. Resourceful and persistent in overcoming obstacles, even when confronted with ambiguity or barriers. Takes pride in delivering high quality work.

• Applies extensive knowledge of regulatory requirements, industry drivers and practices to develop innovative approaches and manage the work of a team. Anticipates potential changes and challenges the status quo to drive continuous improvement.

• Develops and manages plans, establishes timelines, sets standards for performance and balances commitments to complete multiple activities and achieve results for areas of responsibility.

• Strong interpersonal skills and demonstrable ability to accommodate differing views to influence an agreed upon resolution. Identifies potential for conflict and takes preventive action.

• Effective builder of cohesive teams and facilitates team alignment and achievement of common goals. Independently engages internal and external stakeholders to establish productive collaborative relationships.

• Establishes objectives for areas of responsibility and plans for successful outcomes, consistent with Regulatory Affairs strategy.

• Establishes objectives for areas of responsibility and plans for successful outcomes, consistent with Regulatory Affairs strategy.

• Demonstrates advanced skill and insight in gathering, analyzing and applying key information to solve complex 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 and departmental goals. Serves as a role model, encouraging others to behave ethically; takes accountability for self and group actions.

JOB COMPLEXITY:

• Capable of proactively assessing workload, trends, tasks and priorities for cross-functional activity.

• Plans and executes multiple projects or activities, considering alternative methods and contingency plans to avoid potential issues.

• Designs and implements solutions to address cross functional project level challenges, taking into consideration the broader impact.

• Engages, influences and collaborates with stakeholders on cross-functional projects.

WORKING CONDITIONS:

• Travel approximately 15%

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Recruiters and staffing agencies should not contact Exelixis, Inc. through this page. We require that all recruiters and staffing agencies have a signed contract on file and be assigned a specific search by our human resources department. Any resumes submitted through the website or directly by recruiters or staffing agencies that do not meet the above-mentioned criteria will be considered unsolicited and the company will not be responsible for any related fees.

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