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Manager, Regulatory Affairs
Gilead Sciences is continuing to hire for all open roles. Our interview process may be conducted virtually and some roles will be asked to temporarily work from home. Over the coming weeks and months, we will be implementing a phased approach to bringing employees back to site to ensure the health and safety of our teams.
For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.
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.
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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.
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Job posted: 2022-04-24