Sr Regulatory Affairs Labeling Director

SUMMARY/JOB PURPOSE:

Responsible for creating, updating, and maintaining product information and labeling documentation for all relevant Exelixis products across our product portfolio. This position plays an important role in company-wide initiatives around end-to-end labeling and provides dedicated support on Regulatory-related activities and deliverables.   This role requires an extensive knowledge of the roles and responsibilities of Regulatory Affairs spanning both clinical and commercial phases of drug development, and how Regulatory Affairs connects with other functional areas.  Familiarity with clinical trials (design, results, conduct) is especially important, given the intended cross-functional partnership on clinical trial related activities and Regulatory deliverables.  Has experience specifically in the Regulatory Affairs Global Labeling function.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Independently leads and manages the Exelixis Labeling Working Group on the development, review, approval, and maintenance of the Company Core Data Sheet (CCDS), Company Core Safety Information (CCSI), USPI, EU SmPC and Rest of World (RoW) labeling.   

• Works with Regulatory Strategy Leads on Target Product Labeling for development compounds

• Owns the end-to-end labeling process including the development and management of all related Standard Operating Procedures (SOPs) and Work Instructions  

• Independently manages complex labeling negotiations with regulatory authorities.  

• Provides strategic input and operational leadership and oversight of regulatory labeling activities for all products. Leads development of labeling strategies across all stages of labeling lifecycle.  

• Represents RA Labeling across all organizational levels relevant to assigned products and/or other activities. Accountable for presenting labeling proposals to the Exelixis Labeling Committee (ELC).  

• Leads one or more teams in the preparation and submissions of USPIs as part of BLAs, sBLAs, NDAs, or sNDAs.  Prepares submission-ready labeling documents.  

• Maintains labeling documents in the electronic document management system and relevant labeling trackers as appropriate.  

• Monitors worldwide regulation changes pertaining to Labeling regulations.  

• Leads or contributes to various continuous improvement projects related to labeling.  

• Supports activities to provide a state of readiness for Health Authority inspections within Global Labeling and supporting local country (LOC) activities, including the development of strategic internal audit plans, and the execution of internal audits.  

• Understands compliance related issues and translates them to Regulatory actions and responsibilities.  

• Develops and executes plans for internal compliance checks, verifying adherence to Regulatory processes, identifying any gaps and solutions such as process improvements and tracking tools.  

• Provides direction / mentorship to other individuals.

SUPERVISORY RESPONSIBILITIES:

• None

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:

Education/Experience:

• PharmD/PhD and a minimum of 12 years relevant experience; or,  

• MA/MS/MBA and a minimum of 13 years relevant experience; or,  

• BA/BS and a minimum of 15 years relevant experience; or, 

• Equivalent combination of education and experience.

Experience/The Ideal for Successful Entry into Job:

• 8+ years’ experience in prescription drug labeling.

Knowledge/Skills:

• Develops and manages plans, establishes timelines, sets standards for performance. Proactively balances commitments and overcomes challenges to complete multiple activities and achieve results. Takes pride in delivering high quality work.  

• Applies extensive knowledge of the regulatory framework, industry drivers and practices to develop innovative approaches and manage complex 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 cross-functional groups of colleagues.  

• Strong interpersonal skills and ability to accommodate differing views to influence an agreed upon resolution.  

• Manages effectively performing teams, facilitates team alignment and achievement of common objectives. Engages internal and external stakeholders to establish pr