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Sr. Regulatory Affairs Associate

Company: Gilead Sciences, Inc.
Location: California
Posted on: June 10, 2021

Job Description:

Gilead Sciences is continuing to hire for all open roles. Our interview process may be conducted virtually and some roles will be asked to temporarily work from home. Over the coming weeks and months, we will be implementing a phased approach to bringing employees back to site to ensure the health and safety of our teams.

For Current Gilead Employees and Contractors:

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

Job Description

The Sr. Regulatory Associate will support programs in the HIV therapeutic area, including marketed and/or investigational products. She/he may serve as the US regulatory lead and the primary contact with the FDA for the assigned project(s).

  • May lead designated regional regulatory activities of the Regulatory Project Team.

  • Represents regional Regulatory Affairs or may serve as Regional Lead on cross-functional/cross-regional Regulatory Submission Teams.

  • May participate on other sub-teams (e.g., Study Management, Clinical, Nonclinical, Biomarkers teams).

  • Responsible for preparing moderately complex regulatory submissions which require interactions with departments outside of Regulatory Affairs for investigational and commercial products.

  • May serve as contact with local Regulatory Authorities.

  • Initiates or contributes to local and/or global process improvements which have a significant impact on business.

  • Responsible for development and acquisition of required regulatory skills and knowledge, under guidance of immediate manager.

  • Work is performed under minimal direction of a Senior Regulatory Affairs professional.

Knowledge & Skills:

  • Strong organizational skills and ability to work on several projects in alignment with timelines.

  • Strong verbal and written communication skills and interpersonal skills.

  • General understanding of regulatory requirements, including ICH requirements and regional requirements for assigned territories.

  • Is recognized as a knowledgeable resource within the department on limited topics.

  • Work is performed under minimal supervision of a Regulatory Affairs professional.

Education, Skills & Experience:

  • 5+ years of relevant training or industry experience with BS/BA.

  • 3+ years of relevant training or industry experience with advanced degree.

  • Degree in a scientific field is preferred.

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 for assistance.

For more information about equal employment opportunity protections, please view the 'EEO is the Law' poster.




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.

Keywords: Gilead Sciences, Inc., Alexandria , Sr. Regulatory Affairs Associate, Other , California, Virginia

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