Job Search Results - Biospace
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Your search returned 16 jobs



4/16/2015
Radius Health
Morristown, NJ

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...

4/10/2015
Raptor Pharmaceuticals
Novato, CA

Summary Description 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...

4/10/2015
Xellia Pharmaceuticals
Raleigh, NC

POSITION SUMMARY 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,...

4/9/2015
Camargo Pharmaceutical Services
Cincinnati, OH

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...

4/8/2015
Otonomy, Inc.
San Diego, CA

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...

4/7/2015
Regulus Therapeutics, Inc.
San Diego, CA

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...

4/7/2015
Biotecher
San Francisco East Bay, CA

THE COMPANY 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....

4/6/2015
Amicus Therapeutics, Inc.
Cranbury, NJ

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...

4/1/2015
Karyopharm Therapeutics
Newton, MA

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,...

3/30/2015
Relypsa Inc.
Redwood City, CA

Company Overview 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...