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Associate Director, Regulatory Affairs - Labeling

Foster City, CA, USA | Gilead Sciences

  • Industry:
    Pharmaceutical / Biotech
  • Position Type:
    Full-Time
  • Functions:
    Regulatory Affairs
  • Experience:
    10-12 years
Job Description:
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Job Description

Gilead is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead’s therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions. Within the Gilead family, Kite Pharma are a leader in engineered T cell therapy, changing the paradigm of cancer treatment with what is potentially the biggest breakthrough since the introduction of combination therapy. With an unrelenting drive and a singular focus on our strategy to bring life-saving therapies to patients. 


Specific Responsibilities: 


The Associate Director in Regulatory Affairs Labeling is responsible for providing strategic and operational leadership in the area of product labeling, primarily for marketed and investigational products in Gilead’s oncology therapeutic area, including cell therapy products with Kite Pharma This role will develop and implement regulatory labeling strategies, directly author and manage Core Labeling as well as US Prescribing Information, participate in and contribute to global NDA/sNDA or BLA/BLS filings, and manage complex labeling negotiations with Regulatory Authorities.Experience will be gained in labeling not only for the US, but also for EU, Canada, Japan, Australia, and Rest of World countries.This is an opportunity to work cross-functionally as well as globally, and be recognized as an expert resource for regulatory labeling advice in other departments.


This role will develop and implement regulatory labeling strategies, directly author and manage Core Labeling as well as US Prescribing Information, participate in and contribute to global NDA/sNDA filings, and manage complex labeling negotiations with Regulatory Authorities.Experience will be gained in labeling not only for the US, but also for EU, Canada, Japan, Australia, and Rest of World countries.This is an opportunity to work cross-functionally as well as globally, and be recognized as an expert resource for regulatory labeling advice in other departments.


Essential Duties and Job Functions:


1. Preparation of Development Core Safety Information (DCSI), Company Core Datasheets (CCDSs), Target Product Labeling (TPLs) and US Prescribing Information (USPIs), as applicable, for products across assigned therapeutic areas, either through the oversight of others or individually.

 2. Facilitating Core Labeling Working Group meetings for assigned products and leading one or more teams in preparation and submission of US Prescribing Information as part of New Drug Applications or supplements and, as applicable, associated documentation to US FDA, as well as managing complex negotiations with Regulatory Authorities.

 3. Contribute to developing labeling strategies for a product being developed across multiple indication and therapeutic areas, or multiple products across one or more therapeutic areas; and serve as the central contact for the global regulatory team for interpreting the content and messaging of the CCDS and USPI, with an understanding of the nuances of ex-US labeling; participate in Product Safety Committee discussions regarding DCSIs/CCDSs. 

4. Training cross-functional team members to ensure compliance with labeling-related SOPs and consistency in labeling content and processes across all products in assigned therapeutic areas. 

5. Contributing to and/or leading the development of systems and local/global process improvements that have a significant impact on the business.


Knowledge, Experience and Skills: 


Ten years of experience in Regulatory Affairs or other relevant industry experience and a BS/BA are required; 8 years of experience with an advanced degree (scientific field preferred). 


At least 4 years of direct experience in prescription drug/biologic labeling are required and experience in direct interface with FDA and EMA in the submission of labeling and labeling negotiations is preferred. Experience representing Labeling on cross-functional submission teams and Regulatory Project Teams is desirable.


Working knowledge of technical aspects associated with labeling such as electronic systems is desirable.In-depth knowledge of drug development and the pharmaceutical business is preferred.


Previous people management experience is preferred.


Excellent written and verbal communication abilities are essential. The candidate must possess excellent organizational, project management, and negotiations skills


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