Senior Reg Affairs Associate - Inflammation
Senior Reg Affairs Associate - Inflammation
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
The Sr. Regulatory Associate will support programs in the Inflammation 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.
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 firstname.lastname@example.org for assistance.
Following extensive monitoring, research, consideration of business implications and advice from internal and external experts, Gilead has made the decision to require all U.S. employees and contractors to receive the COVID-19 vaccines as a condition of employment. Full vaccination is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.\u200b
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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:
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