Cook Pharmica, LLC
Cook Pharmica is a biopharmaceutical contract development and manufacturing organization (CDMO) with process development, clinical and commercial bulk drug substance manufacturing, formulation development, clinical and commercial parenteral drug...
Responsible for the support of Pre and Post approval regulatory affairs activities as directed by the Senior Manager which may include:
Annual reports, adverse event reports, electronic assembly and publication of FDA submissions, labeling,...
Bellicum Pharmaceuticals, located in the Houston Medical Center, is a clinical stage pharmaceutical company focused on discovering and developing novel cellular immunotherapies for various forms of cancer, including both hematological and solid...
Revance Therapeutics, Inc.
This position leads the execution, maintenance and monitoring of Regulatory submissions in compliance with approved procedures. This position recommends regulatory strategy and manages global regulatory submissions for development...
SUMMARY OF THE JOB: Summarize the overall purpose of the position.
Manages the coordination, compilation and submission of all medical device applications; including new product development activities and base business regulatory compliance, to...
Rigel Pharmaceuticals, Inc.
South San Francisco,
This position will assist in the general regulatory affairs and regulatory compliance functions of the company, with specific responsibility for the global regulatory development for assigned product(s), indication(s), and regulatory support for...
AnaptysBio is a privately-held antibody development company advancing first-in-class programs in inflammation and immuno-oncology generated using our proprietary SHM-XEL™ platform.
Multiple antibodies emanating from our pipeline are currently...
AstraZeneca Pharmaceuticals LP
There are 2 roles open for the RAD positions--each representing a different therapeutic area: Oncolgy and RIA. Description: The Regulatory Affairs Director (RAD) is accountable for the development and implementation of the regulatory strategy for a...
Location: San Francisco, California OR Louisville, Colorado
AntriaBio focuses its activities on research, development, registration and manufacturing of innovative controlled release technology based pharmaceuticals. OUR VISION is to build a...
Anthera Pharmaceuticals, Inc.
The Sr. Director, Regulatory Affairs and Chemical Manufacturing & Controls (CMC) will report to the Senior Vice President, Chief Regulatory Officer. The Sr. Director, Regulatory Affairs and CMC will be responsible for...