Manager, Regulatory Affairs, Liaison, Virology
Manager, Regulatory Affairs, Liaison, Virology
United States - California - Foster CityUnited States - New Jersey - Morris PlainsUnited States - Washington - Seattle
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
Unique opportunity to be a regional/global regulatory strategist for approved products in the dynamic Virology team at Gilead. Collaborate with talented cross functional teams in this foundational therapeutic space at Gilead.
**Prefer candidates who can work from Foster City, CA office but also open to remote candidates**
Regulatory Affairs Manager Job Details
- May serve as Regional Lead on 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 Subteams (eg, Study Management, Clinical, Nonclinical, Biomarkers)
- May serve as contact with local Regulatory Authorities
- Responsible for preparing and submitting moderately complex regulatory documents 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. Examples include safety reports, amendments, supplements and license renewals to clinical trial applications and marketing authorizations, and original INDs/CTAs and NDAs/MAAs for assigned territories.
- May provide regulatory expertise to submission teams on specified projects and topics.
- Provides input to senior Regulatory Affairs professionals in the preparation of country specific labeling (region specific).
- Responsible for ensuring product packaging and associated information is updated and maintained in accordance with the product licenses (region specific).
- Responsible for own self-development and acquisition of required regulatory skills and knowledge, under guidance of immediate manager
- Initiates or contributes to local process improvements which have an impact on the working of the Regulatory Affairs function or other departments.
- May contribute to training of staff under direction of Sr Manager, Assoc Director or Director.
Knowledge & Skills
- Strong organizational skills and ability to work on several projects with tight timelines.
- Strong verbal and written communication skills and interpersonal skills.
- Must have in-depth knowledge of regulatory requirements, including ICH requirements and regional requirements for assigned territories
- Demonstrates capability to act as primary Company contact with Regulatory Authorities
- Work is performed under minimal direction of a senior Regulatory Affairs professional.
- Is recognized as a knowledgeable resource within the department on a range of topics.
Education & Experience:
- 7+ years of experience in Regulatory Affairs or other relevant industry experience with BS/BA
- 5+ years of experience in Regulatory Affairs or other relevant industry experience with advanced degree
- Degree in a scientific field is preferred.
About Gilead Regulatory Affairs
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.
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
For more information about equal employment opportunity protections, please view the EEO is the Law' poster.
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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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