Associate Director/Director, Regulatory Affairs (Non-Clinical)

Highly Competitive Salary
  1. Permanent
  2. Senior/Director & VP
  3. United States
Maryland
Posting date: 29 Apr 2019
RA.KW.22994_1556572602

At ProClinical, we are seeking an individual to fill the role of Associate Director/Director of Non-Clinical Regulatory Affairs, based in Maryland.

Responsibilities

  • Conceptualize, develop, revise, and finalize toxicology study designs and reports.
  • Draft nonclinical sections for IND submissions to the FDA, as well as required minor and major submissions to ensure regulatory compliance.
  • Manage and monitor nonclinical studies (GLP and non-GLP) at the CROs and ensure global regulatory/compliance requirements are met/exceeded.
  • Review and edit CRO nonclinical toxicology study reports, analyze and interpret data, define PK/PD correlations, partner in PK modeling and parameter estimation, and coordinate report finalization with CROs upon internal review and team communication, ensuring consistency with global regulatory and compliance requirements.
  • Provide critical input on discovery and nonclinical development strategy.
  • Partner with and provide subject matter expertise to key internal functions and their external contractors or collaborators.

Skills And Qualifications

  • PhD in Toxicology and DABT required with about 5 years of industry experience in biopharmaceutical development. Ph.D. in Biological Sciences acceptable with DABT certification.
  • Broad experience with large molecules, oncology and/or non-oncology targets.
  • Strong knowledge of FDA, EMA, and ICH guidance documents including GLP regulations.
  • Required experience in authoring INDs, preparing/presenting science-based responses to regulatory questions.
  • Deep understanding of QA, regulatory, and clinical functions.
  • Synthesize and interpret diverse, multidisciplinary data sets.
  • Strong written, verbal, and interpersonal communication skills.

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.

#LI-KW1

close