Associate Director/Director, Regulatory Affairs

Highly Competitive Salary
  1. Permanent
  2. Senior/Director & VP
  3. United States
Rockville, Maryland
Posting date: 29 Apr 2019
RA.KW.22993_1556569829

ProClinical, in support of our client, are seeking an individual to fill the role of Associate Director/Director, Regulatory Affairs, based in Maryland.

Responsibilities

  • Act as a point of contact for Regulatory Agencies between US and China teams.
  • Lead US and/or global IND filings with high quality and expedited fashion. Develop, review and complete submission documents in collaboration with other functional disciplines. Achieve this in a collaborative and trusting relationship with regulators and other external stakeholders
  • Assist in preparation and submission of INDs and IND amendments.
  • Assist in preparation and submission of international Clinical Trial Applications.
  • Participate in the development and implementation of short- and long-term Regulatory plans for key projects.
  • Guide Nonclinical, CMC and Clinical personnel about the content and format requirements for INDs, CTAs and NDAs/BLAs.
  • Perform nonclinical, CMC and clinical GAP analyses of dossiers being considered for registration of products in the U.S.
  • Lead preparations and delivery of FDA communications with Clinical Development Team for US and other Health Authority interactions.

Skills and Qualifications

  • BA or higher in an applied science field. PhD highly preferred.
  • Regulatory Affairs experience in drug development and/or registration activities is a must.
  • Outstanding working understanding of the U.S. regulatory environment.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Kyle Weber at (+1) 646-367-2618 or upload your resume on our website - www.proclinical.com.

A full job description is available on request.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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