The Manager of GCP Compliance leads and directs GCP compliance activities that primarily support the Development Organization. The position helps ensure GCP compliance by assisting with the development and implementation of...
Manage and direct the company’s global regulatory submissions including both US (INDs, NDAs) and ex-US (CTAs,
MAA) filings working with internal functional groups, CROS, and consultants. The incumbent must be well-versed in FDA
and ICH regulations...
About Aimmune Therapeutics, Inc.
Aimmune Therapeutics is a clinical-stage biopharmaceutical company located in Brisbane, California, in the biotechnology hub south of San Francisco. The company is developing desensitization treatments for food...
The Senior Director of Regulatory Affairs and Quality Assurance is responsible for developing and directing the global regulatory strategy, objectives, policies and programs from IND through NDA or BLA and commercialization, and for...
MacroGenics is a leader in the discovery and development of innovative medicines that utilize our next generation antibody-based technologies. Our team of 200+ dedicated individuals is advancing a pipeline of product candidates to treat patients...
Regulus Therapeutics, Inc.
Regulus Therapeutics Inc. (NASDAQ:RGLS) is a biopharmaceutical company leading the discovery and development of innovative medicines targeting microRNAs. Regulus has leveraged its oligonucleotide drug discovery and development expertise to develop...
Growing and well-respected biomedical (clinical, basic and applied) research firm has openings atUSAMMDA. If you are passionate about research, and are looking for a firm that shares your passion, and provides competitive salaries with a strong...
The Regulatory Affairs Specialist will prepare the regulatory submissions and interact with regulatory agencies/health authorities to obtain and maintain product approvals with a focus on China and Japan. Assist with ROW submissions as required....
Responsible for leading CMC regulatory strategy development and implementation that incorporates risk identification and contingency planning for assigned development and post approval programs.
• Plan and coordinate...
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...