The Regulatory Affairs Director CMC acts as single contact point for CMC regulatory strategy for critical submissions: INDs, NDAs, MAAs as well as Investigational Medicinal Products (IMPs) The successful candidate will oversee all CMC regulatory...
The Director Regulatory Operations is responsible for leading all aspects of regulatory operations which are necessary to ensure timely, high quality and compliant regulatory submissions to the FDA and ex-US regulatory...
US Agent for Xellia to the Agency
? Maintenance of Xellia Drug Establishment Registrations (DER) covering all sites
? Drug Listing, Create NDC numbers
? Provide information on GDUFA requirements and GDUFA fees
? Major driver,...
Camargo Pharmaceutical Services
Camargo Pharmaceutical Services is now seeking a Vice President of Scientific and Regulatory Affairs for our Cincinnati Corporate office. Position provides non-clinical and clinical development planning and strategic regulatory consulting to...
The R/A Manager will lead the coordination of all administrative activities needed in the development, submission and tracking of regulatory filings associated with NDA post-approval activities. Participate in the development and implementation of...
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 a...
San Francisco East Bay,
Bay Area based medical device company that develops and globally markets novel Class III medical devices. This well established, pioneering, mid-sized device company offers a collaborative work environment and competitive compensation....
Amicus Therapeutics, Inc.
SUMMARY OF POSITION
The Director, CMC Regulatory Affairs will provide regulatory leadership and oversight to the Amicus Therapeutics cross-functional teams in both pre- and post-approval roles. Emphasis will be primarily on the biologics product...
Karyopharm Therapeutics is actively seeking a Vice-President Regulatory Affairs and Quality Assurance to join our rapidly growing organization in Newton, Ma. The incumbent will establish the vision for the Regulatory and Quality Assurance Groups,...
Relypsa, Inc. is a late clinical-stage pharmaceutical company leading the discovery and development of novel non-absorbed polymeric drugs for important applications in cardiovascular and renal diseases. Relypsa's lead product...