Manager, Regulatory Affairs, Liaison (Oncology)
Manager, Regulatory Affairs, Liaison (Oncology)
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
Great opportunity in the growing Oncology team at Gilead. Opportunity to be a regional regulatory strategist in the growing Trodelvy franchise. Support upcoming regional filings as well as indication expansion (including Health Authority Meetings and global roll out of studies). Work with talented cross functional teams on this exciting compound that is the key driver for Gilead Oncology in the future.
**Note: This role can be based out of Foster City, CA/ Morris Plains, NJ / Seattle, WA. **
- 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, Skills & 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.
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.
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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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