Sr. Regulatory Affairs Associate
Company: Gilead Sciences, Inc.
Location: California
Posted on: June 10, 2021
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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. 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. 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. 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. For more information about equal employment opportunity
protections, please view the 'EEO is the Law' poster. NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT PAY TRANSPARENCY NONDISCRIMINATION PROVISION 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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