SR. DIRECTOR, CMC REGULATORY AFFAIRS

SUMMARY/JOB PURPOSE:

This role provides CMC Regulatory expertise and leadership for commercial and development projects. This role recognizes the different requirements and restrictions for external data communication and presentation and represents the Regulatory considerations and point of view. This role also exercises strategic approaches for Health Authority filings and communications.  This role manages a CMC team who manages relevant submissions to US investigational new drug applications (IND), ex-US clinical trial applications, and new drug applications (NDAs). This role works closely with the Chemistry, Manufacturing and Controls (CMC), Regulatory Affairs, and Quality Assurance departments, as well as with cross-functional project teams.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Coordinate CMC-related submissions to regulatory authorities and track progress of submission, review, and approval, including submissions across multiple countries and clinical studies.

• Help coordinate responses to questions. Ensure appropriate archiving of documentation.

• Support cross-functional project teams on core Module 3 development, writing, and appropriate updates.

• Facilitate transition of core Module 3 documents to regional format (e.g. IMPD, QOS).

• Review chemistry, manufacturing, and controls-related documentation (e.g., INDs, IMPDs, NDAs, BLAs) for compliance with regulatory guidances and as appropriate for the phase of development; may be required to provide relevant content or develop documents and templates, as necessary.

• Track and manage regulatory actions associated with post-approval and development stage changes through completion.

• Liaise internally with other members of the Regulatory Affairs department to coordinate CMC changes with other aspects of the development programs.

• Ensure continued regulatory compliance through adherence to change control procedures and completion of regulatory impact assessments.

• Monitor CMC regulations and guidances to assess relevant changes and implications to current and future development and commercial activities.

• Contribute in the implementation of processes and procedures, including developing and authoring internal work instructions and company SOPs.

• Work with cross-functional teams to identify and support continuous improvement opportunities for processes and systems.

• Provide strategic and forward-looking guidance regarding processes and systems surrounding review committees.

• Has people management responsibility and oversight (through direct reports and as an individual contributor as needed) of other compliance-related initiatives within Regulatory and cross-functionally

• 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.

• Provide leadership within the Regulatory department, 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.

SUPERVISORY RESPONSIBILITIES:

• Directly supervise employees.

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

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:

• Minimum of sixteen years of pharmaceutical industry and/or regulatory agency experience or the equivalent combination of experience and education/training

• Minimum of twelve years of regulatory experience in a position of substantial responsibility 

• Prior experience working with Health Authorities and/or review divisions at FDA required

• Experience in oncology preferred

Knowledge/Skills:

• Demonstrated knowledge of US and international regulatory requirements pertinent to this role.

• Uses broad expertise or unique knowledge and skills to contribute to development of company objectives and principles and to achieve goals in creative and effective ways.

• Develops technical and/or business solutions to complex problems.

• Exercises problem solving, strategic thinking skills with ability to impact and influence

• Guides the successful completion of major programs, projects and/or functions.

• Interprets, executes and recommends modifications to departmental and cross-functional processes and standards.

• Leads or manage the work of others by providing guidance to subordinates or teams based on organizational goals and company policy, with responsibility for results, including costs, methods and staffing.

• Trains staff.

• Performs a variety of complicated tasks with a wide degree of creativity and latitude.

• Responsible for maintaining a working knowledge of regulatory requirements and guidelines and for communicating changes in regulatory information to departmental and team colleagues

• Has good general knowledge of other related disciplines.

• Applies strong analytical and business communication skills.

WORKING CONDITIONS:

• Environment: primarily working indoors, performing clerical work

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If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us!

DISCLAIMER 
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification.  It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.

We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.