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....
The primary responsibility of this role, Principal Specialist, Compliance
• Design, implement and maintain audit program for GMP Computerized
system across Biotech sites. Organize, compile, edit, and prepare
internal audit reports and...
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...
Calmoseptine, Inc. is a nationally established medical company that manufactures, markets and sells its unique medical product to hospitals, nursing homes and pharmacies throughout the USA with affiliate companies in Canada, Philippines, Australia...
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,...
• Lead and manage international regulatory projects by working with cross functional development teams to ensure regulatory filings are completed in a timely manner.
• Recommend and develop regulatory strategies related to international...
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...
Intarcia Therapeutics, Inc.
The Associate Director or Director, Regulatory Affairs will be responsible for managing all regulatory aspects (Nonclinical, Clinical, CMC). The responsibilities include working closely with cross-functional teams to support product development and...