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Executive Director, Regulatory Affairs
About the Company
Pioneering developer & manufacturer of innovative therapeutic medicines
Industry
Biotechnology
Type
Public Company
Founded
1980
Employees
10,001+
Categories
Biotechnology
Biotechnology and Pharmaceuticals
Biotech
Health Care
Pharmaceutical
Pharmaceuticals
Academic Research
Manufacturing
Geno
Executive Director, Regulatory Affairs, Labeling page is loaded
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locations
United States - California - Foster City
United States - New Jersey - Parsippany
time type
Full time
posted on
Posted 5 Days Ago
job requisition id
R0041342
For Current Gilead Employees and Contractors:
Pleas
Title: Senior/Executive Director Regulatory Affairs
Summary: A growing immune-oncology company is seeking a Senior/Executive Director of Regulatory Affairs to join the team in executing regulatory strategies and supporting the development of their product pipeline with an emphasis on early stage development.
The S/E Director of Regulatory Affairs
Job Source: EPM Scientific - Phaidon International
**For Current Gilead Employees and Contractors:**
Please log onto your Internal Career Site (yworkday.com/gilead/d/inst/13102!CK5mGhIKBggDEMenAhIICgYI1A0QtgI~/cacheable-task/2997$2151.htmld#backheader=true) to apply for this job.
At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV,
For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site (https://www.myworkday.com/gilead/d/inst/13102!CK5mGhIKBggDEMenAhIICgYI1A0QtgI~/cacheable-task/2997$2151.htmld#backheader=true) to apply for this job.
At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such
The Position:
Join our dynamic Regulatory Affairs team as a Director, Regulatory Affairs, where you will be the driving force behind our development programs from preclinical candidate designation through drug approval. We are looking for a strategic thinker and regulatory expert to provide leadership and guidance. As the Global Program Lead, you
Meets clinical-stage biopharmaceutical client based in the Bay Area is seeking a highly motivated individual to join their growing regulatory affairs group. The Associate Director / Director, Regulatory Affairs will work closely with the Regulatory Affairs team and other departments to develop and implement regulatory strategies for the company's r
The Position:
Join our dynamic Regulatory Affairs team as a Director, Regulatory Affairs, where you will be the driving force behind our development programs from preclinical candidate designation through drug approval. We are looking for a strategic thinker and regulatory expert to provide leadership and guidance. As the Global Program Lead, you
Job Source: BioSpace, Inc.
Executive Director, Regulatory Affairs
San Francisco, CA, United States
Executive Director, Regulatory Affairs
About the Company
Prominent clinical-stage biopharmaceutical company
Industry
Pharmaceuticals
Type
Public Company
About the Role
The Company is seeking an Executive Director of Regulatory Affairs with a focus on strategic and operational leadership. The successful candidate will be responsible for providing mentorship on general regulatory strategies, requirements for clinical studies, and marketing approval in domestic and international markets. This role involves critical issue management, advice on regulatory interactions, and overseeing the preparation and submission of regulatory documentation. The Executive Director will also be tasked with maintaining awareness of the global regulatory environment, integrating regulatory expertise with business knowledge, and ensuring that the company's regulatory processes are in line with industry standards.Candidates for this position should have a PhD with at least 10 years' experience in pharmaceutical regulatory affairs, or a B.S/M.S. with over 12 years in biotech or pharmaceutical regulatory affairs. The ideal candidate will have a proven track record of significant regulatory accomplishments, including experience with INDs/CTAs, BLAs/MAAs, and lifecycle management. Strong leadership, interpersonal, and negotiation skills are essential, as is the ability to work effectively in a global, cross-functional team. The role requires a professional with a very strong strategic acumen, the ability to balance short-term and long-term goals, and a talent for creative problem-solving. The Executive Director will also be expected to manage a regulatory team, build partnerships with key stakeholders, and ensure that the company's regulatory strategies align with its business objectives.