Biotest Pharmaceuticals Corporation
documents for submission to governmental regulatory agencies such as the U.S. Food and Drug Administration. Serves as a liaison with regulatory agencies and contractors, as well as an information source regarding product and assay development...
Ultragenyx Pharmaceutical Inc.
Why Join Us
Ultragenyx is a clinical stage biotechnology company committed to bringing to market novel products for the treatment of rare and ultra-rare diseases with an initial focus on serious debilitating metabolic genetic diseases. Founded in...
Summary of Position:
Reporting to the CEO, the Vice President of Regulatory Affairs will be responsible for developing the global regulatory strategy for development-stage programs including CMC, regulatory submissions, regulatory compliance,...
Summary of Position:
The Clinical QA Manager is responsible for providing support in the execution of the Company’s audit plans and strategies to ensure overall quality system compliance for Clinical. This role will have a heavy focus on the...
Revance Therapeutics, Inc.
The Regulatory Affairs Associate provides support for the preparation, submission and archival of accurate information to Health Authorities ensuring compliance with regional registration requirements, company policies and procedures under the...
South San Francisco or Sunnyvale,
Pharmacyclics, an AbbVie Company, based in Sunnyvale, CA represents the single largest acquisition AbbVie has ever made, and is key to AbbVie’s corporate strategy to add another very significant growth platform and diversification. Pharmacyclics...
The Director, Regulatory Affairs, CMC is responsible for developing and implementing global regulatory CMC strategies to secure and maintain market access for product(s) in line with business objectives, and in coordination with key internal...
Five Prime Therapeutics, Inc.
South San Francisco,
Five Prime Therapeutics, Inc. (NASDAQ: FPRX) is a clinical-stage biotechnology company focused on discovering and developing transformative protein-based medicines for patients with serious unmet medical needs. The company has an emerging portfolio...
Alder Biopharmaceuticals, Inc.
Regulatory Affairs Manager
The responsibilities of this newly created position will focus on supporting the development and implementation of regulatory strategies for Alder BioPharmaceuticals development programs. This includes responsibility for...
This position leads and establishes strategic and technical direction for the GLIADEL Quality Operations organization, including quality assurance and quality control. Serves as the technical expert in the area of quality assurance, and analytical...