Manager, Regulatory Affairs Labeling

Location
94404, Foster City
Posted
Oct 25, 2018
Required Education
Bachelors Degree
Position Type
Full time

Manager, Regulatory Affairs Labeling

 

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

 

Job Description

Specific Responsibilities:

The Manager in Regulatory Affairs Global Labeling is responsible for providing strategic and operational leadership in the area of product labeling, primarily for products within the liver fibrosis area (e.g. NASH, Primary Biliary Cirrhosis, Primary Sclerosing Cholangitis).

 

This role will develop and implement regulatory labeling strategies; author and manage Core Labeling, Target Product Labeling and/or US Prescribing Information; contribute to global 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.

 

Essential Duties and Job Functions:

• Preparation of Development Core Safety Information (DCSI), Company Core Datasheets (CCDSs), Target Product Labeling (TPLs) and US Prescribing Information (USPIs), as applicable, for products in assigned therapeutic area.

• Facilitation of Core Labeling Working Group meetings for assigned products. Support the preparation and submission of US Prescribing Information as part of New Drug Applications or supplements. Manage complex negotiations with Regulatory Authorities.

• Contribute to the development of labeling strategy for assigned products. Develop regulatory skills and working knowledge of competitor labeling, CCDS/USPI requirements, and global labeling.

• Contribute to and review applicable regulatory documentation; review artwork for US labeling.

• Contribute to development of systems and local/global process improvements that have a significant impact on the business.

 

Knowledge, Experience, and Skills:

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

• At least three years of direct experience in prescription drug/biologic labeling, including 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.

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

 

Meet the team:

https://regulatoryaffairs-careers.gilead.com/

 

For jobs in the United States:

As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact careers@gilead.com for assistance.

 

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Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.

Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.

 

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

 

To apply, visit: http://apptrkr.com/1321892