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ALX Oncology is a clinical-stage immuno-oncology company focused on helping patients fight cancer by developing therapies that block the CD47 checkpoint pathway. Our lead candidate, evorpacept, is a next-generation CD47 blocking therapeutic that combines a high-affinity CD47 binding domain with an inactivated proprietary Fc domain. For more informa
JOB TITLE: Senior Director, Regulatory Affairs
DEPARTMENT: Regulatory Affairs
TYPE: Full-Time
HI-Bio, Inc. is a clinical-stage biotechnology company based in South San Francisco, California. Our shared purpose is to transform the lives of patients with severe immune-mediated diseases by developing novel targeted therapies with outsized clinical imp
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
Company Location:
Bay Area
Comp:
150K-220K
Position Reports to:
VP of Regulatory and Quality
Director of Regulatory Affairs -San Francisco
We are seeking a highly motivated and experienced Senior Director of Regulatory Affairs for a Medical Device Orthopedic Portfolio. This person will lead interactions with regulatory agencies globally and help
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
Become a genetic navigator.
Our mission is to discover new genetic insights and translate them into new precision medicines. With an unparalleled commitment to changing the way people with severe diseases are treated, our team is at the forefront of accelerating our understanding of the genetic drivers of disease. We celebrate a diversity of persp
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
Description
Reporting to the Vice President, Regulatory Affairs, the Senior Director, Regulatory Affairs – CMCwill be responsible for leading, developing, and executing CMC regulatory strategies on programs ranging from early to late-stage development, including preparation and filing of IND and NDA/MAA submission. This position will sit on cross f
Job Source: Pliant Therapeutics
Senior Director, Regulatory Affairs
San Francisco, CA, United States
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 interactions and negotiations for assigned labeled projects.
Travel Percent
Less than 10%
Functions
Operations
Strategy
Known Requirements
Bachelor's or master's degree in the relevant field required
At least 10 years' relevant industry experience required
Superior leader with at least 4 years' experience in the labelling industry required
Exceptional written, verbal, and interpersonal communication skills required