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HOW MIGHT YOU DEFY IMAGINATION?
At Amgen, every challenge is an opportunity. And every opportunity brings the potential to change lives. Our shared missionto serve patientshas driven our status as one of the worlds preeminent biotechnology companies, reaching over 10 million patients worldwide. Leverage your high-level expertise to lead and forge p
HOW MIGHT YOU DEFY IMAGINATION?
At Amgen, every challenge is an opportunity. And every opportunity brings the potential to change lives. Our shared mission—to serve patients—has driven our status as one of the world’s preeminent biotechnology companies, reaching over 10 million patients worldwide. Leverage your high-level expertise to lead and forg
Job Details
HOW MIGHT YOU DEFY IMAGINATION?
At Amgen, every challenge is an opportunity. And every opportunity brings the potential to change lives. Our shared missionto serve patientshas driven our status as one of the worlds preeminent biotechnology companies, reaching over 10 million patients worldwide. Leverage your high-level expertise to le
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 Affai
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 Affai
Senior Director/Executive Director, Regulatory Affairs
*Onsite 2-3 days weekly in South San Francisco, CA*
Meet has partnered with a pre-IPO biotech that is looking for a Head of Regulatory Affairs to join their team. This will be the first full-time RA hire for the organization and you will be reporting directly into the CEO. Our client is based
This individual will join our client's regulatory team and collaborate with other departments like R&D, Manufacturing, Quality Assurance, and Commercial. Here's what you'll be responsible for:
Preparing Regulatory Submissions: You'll draft submissions for international markets and the FDA, including Technical Documents, Files, Device Applications
RBW is partnering with an innovative late clinical-stage, oncology Biotech (140 FTE) in their urgent and business-critical search for a new Director/AD, Regulatory Affairs. Our client is focused on discovering and developing precision medicines for the treatment of rare cancer and solid tumours.
The candidate will report directly to the Head of RA
Job Source: Rbw Consulting
Executive Director, Regulatory Affairs
Los Angeles, CA, United States
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
Genomics
Therapeutics
Clinical Care
Patient Management
Healthcare
Life Sciences
Personalized Medicine
Medicine
Chemical Products
Specialties
Biologics
Human therapeutics
and Development of novel products
Business Classifications
B2C
Mobile
About the Role
The Company is seeking an Executive Director of Regulatory Affairs to join their team. This pivotal role involves leading and directing regulatory affairs activities within an assigned therapeutic area, ensuring compliance with global and regional laws and regulations. The successful candidate will provide strategic leadership to the regulatory affairs team, oversee the development of regulatory strategies, and engage in effective interactions with regulatory agencies. Responsibilities also include providing regulatory expertise to commercialization teams, contributing to the development of global and regional product labels, and influencing the regulatory legislative environment in line with the company's policy priorities. The role requires a strong leader with the ability to manage and mentor staff, champion change, and foster a culture of continuous improvement.Candidates for the Executive Director of Regulatory Affairs position at the company should have a Doctorate, Master's, or Bachelor's degree in a relevant field, along with a significant amount of experience in regulatory affairs and at least 6 years of managerial experience. The ideal candidate will have a proven track record of leading teams, excellent communication skills, and the ability to understand and communicate scientific and clinical information effectively. They should be adept at setting organizational direction, anticipating strategic issues, and resolving conflicts to achieve positive outcomes. The role demands a leader who can inspire and empower their team, accelerate progress in line with patient needs, and integrate the company's resources to drive results.
Hiring Manager Title
Senior Vice President Global Regulatory Affairs and Strategy