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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
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
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
Senior Director, Regulatory Affairs (Generalist)
Remote Position for West Coast-based candidates, frequent travel to Bay Area required
Meet is partnering with a late stage pediatric rare disease startup looking for a high-level Regulatory Affairs professional to join their team. This position will be reporting into the SVP of Regulatory Affairs an
Senior Director, Regulatory Affairs
About the Company
International labelling organization based in Los Angeles
Industry
Retail
Type
Privately Held
About the Role
The Senior Director, Regulatory Affairs will be responsible for developing and managing labeling for products worldwide as well as overseeing the strategic regulatory leveling HA intera
*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 in South SF and is focused within hematology/oncology, with a promising early development pipeline in the biologics space.
Key Responsibilities
Develop and execute regulatory strategies to streamline the development and approval of innovative medicines
Lead the preparation of relevant regulatory submissions (IND/CTA + BLA/MAA)
Provide regulatory guidance to cross-functional teams in support of clinical pipeline development
Key Qualifications
Minimum 12 years of relevant industry experience
Biologics background highly preferred
Experience leading programs from Pre-IND through BLA
Experience in hematology/oncology highly preferred