Regulatory Affairs Associate II, Virology

Regulatory Affairs Associate II, Virology
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. Gilead's 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 company's five core values. That's 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

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Gilead Regulatory Affairs is a committed and proud team of highly skilled professionals dedicated to helping deliver therapies in the most efficient and effective way to patients with unmet medical need around the world. We bring our passion for science, discovery, and innovative strategic thinking into everything we do. Our advanced regulatory expertise, track record for developing systems and processes, and our commitment to science allow us to play a strategic role as leaders at Gilead and with global regulatory bodies as we seek to develop new therapies for unmet needs.

We are an inclusive and diverse community, which is supported by strong leaders who are committed to providing individual development and growth opportunities while achieving our mission. Our collaborative and supportive structure help support work-life balance for our teams.

Specific Job Responsibilities:

• Responsible for preparing routine regulatory submissions which require some interactions with others in the Regulatory department for investigational and commercial products in line with ICH requirements, regional requirements and scientific and company policies and procedures.
• May have responsibility for preparing submissions, which may include, but are not limited to safety reports, amendments, supplements and license renewals to clinical trial applications and marketing authorizations.
• May provide input to the development of labeling and submit labeling changes, and drug listing. Participate in group meetings and provide tactical approaches to addressing problems of moderate complexity.
• Responsible with manager for development and acquisition of required regulatory skills and knowledge.
• May contribute to local process improvements, which have an impact on the working of the Regulatory Affairs function or other departments.

Specific Education & Experience Requirements:

• BA or BS degree in a scientific field with 4+ years of relevant industry experience.
• Excellent verbal and written communication skills and interpersonal skills are required.
• Excellent organization skills and ability to work on several projects with tight timelines is required.
• Must have a reasonable understanding of regulatory requirements, including ICH requirements and regional requirements for assigned territories.
• Act as a resource on limited topics within the department.
• Work is performed under the general supervision of more senior Regulatory Affairs professionals.
• Work is reviewed for soundness of judgment and overall adequacy.

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.
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