Sr. Regulatory Affairs Associate
Sr. Regulatory Affairs Associate
United States - California - Foster City
Gilead Sciences, Inc. is a research-based bio-pharmaceutical 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. Gileads therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.
Making an impact on a global scale
Inclusion is one of the companys five core values. Thats because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.
When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible
- 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 in line with ICH requirements, regional requirements and scientific and company policies and procedures.
- May provide input to the content of the original label (region specific).
- May be responsible for ensuring product packaging and associated information is updated and maintained in accordance with the product license for assigned products and territories (region specific).
- Responsible for development and acquisition of required regulatory skills and knowledge, under guidance of immediate manager.
- May initiate or contribute to local process improvements, which have a significant impact on the working of the Regulatory Affairs function or other departments.
- Participates in group meetings and presents project status updates and strategic approaches to moderately complex programs/projects.
- 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
- 4+ years of relevant training or industry experience with advanced degree
- Degree in a scientific field is preferred.
- 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.
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 firstname.lastname@example.org 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.
To apply, visit https://gilead.wd1.myworkdayjobs.com/en-US/gileadcareers/job/United-States---California---Foster-City/Sr-Regulatory-Affairs-Associate_R0018693-1
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