Reporting to the President, the Vice President, Clinical and Regulatory Affairs (VPCRA) is responsible for the overall management of the clinical drug development programs of a Midwest biotechnology company and its regulatory processes. The VPCRA...

Therapeutic Proteins International, LLC (TPI) is a world-class developer and commercial manufacturer of finished biosimilar recombinant therapeutic protein products. TPI's products are manufactured in cGMP/BLA compliant facilities using...

Therapeutic Proteins International, LLC (TPI) is a world-class developer and commercial manufacturer of finished biosimilar recombinant therapeutic protein products. TPI's products are manufactured in cGMP/BLA compliant facilities using...

Ensures compliance with standard operating procedures, Food and Drug Administration and ICH guidelines and regulations, and global regulations for the reporting of adverse events to regulatory agencies. Develops guidelines and insures the uniform...

Job Purpose To achieve and maintain product approvals and manage regulatory events related to NAH (Novartis Animal Health) business, by: • Supporting product applications and registrations for all assigned countries/products • Liaising with...

JOB DESCRIPTION: Responsible for all aspects of regulatory affairs strategy and submissions covering the development phases from preclinical,clinical, and registration to post approval requirements. Responsible for development and implementation of...

Plexxikon is a leader in the discovery and development of novel, small molecule pharmaceuticals. The company has utilized its proprietary discovery platform to successfully develop a portfolio of competitively differentiated clinical and preclinical...

SUMMARY: This position assists in developing and implementing short term and long-term clinical supply chain strategies and networks to manage clinical supplies and their distribution whilst effectively managing challenges encountered within supply...

Merck is a global health care leader with a diversified portfolio of prescription medicines, vaccines and consumer health products, as well as animal health products. As part of our global team, you'll have the opportunity to collaborate with...

Perseid Therapeutics LLC's mission is to develop protein drugs to improve human health with an initial focus on patients suffering from disorders treatable by immune suppressive therapy. We use our proprietary technologies to discover, research and...