Regulatory Affairs Scientist

5 months ago
Requisition ID
2017-2443
Job Location(s)
Pittsburgh PA United States
Position Type
Full Time
Company
Cook Myosite Inc.
Category
Regulatory Affairs

Overview

COOK MYOSITE INCORPORATED, a division of Cook Incorporated, is a growing, forward-thinking biotechnology organization seeking a full time, Regulatory Affairs Scientist to join our team. The Regulatory Affairs Scientist will work closely with the Clinical teams to serve as a resource for applying global regulatory requirements and maintain clinical documentation for submission to regulatory authorities. This position will serve as the Regulatory Affairs representative and regulatory point of contact for cross-functional clinical teams and will assist in the development of best practices for Regulatory Affairs processes.        

Responsibilities

  • Provides regulatory advice and interpretation of global regulatory requirements applicable to pre-market and commercial programs.
  • Ensures clinical activities are in compliance with global regulations and resolves complex regulatory issues.
  • Applies interpretation of regulations with respect to phase-appropriate clinical development.
  • Performs regulatory review of clinical documentation to ensure consistent writing style and formatting
  • Assists in writing, reviewing, and editing clinical trial documentation, including clinical protocol, Investigator Brochure, and annual safety reports.
  • Reviews and critically analyzes clinical trial data and independently interprets and summarizes clinical results.
  • Performs literature searches and routine regulatory discovery work (researches regulations, guidelines, industry standards) related to preparation of clinical documentation for routine submissions and marketing approvals.
  • Provides regulatory input on marketing and patient recruitment materials.
  • Writes clear, user-friendly, product information leaflets and labels.
  • Applies scientific and technical knowledge of product to evaluate regulatory impact on product life cycle management.
  • Requires up to 10% travel.

Qualifications

  • M.S. degree in Life Sciences discipline with 5+ years of direct regulatory affairs experience or a Ph.D. in Life Sciences discipline with 2+ years of direct regulatory affairs experience, in biopharmaceutical industry.
  • Regulatory Affairs Certification (RAC) preferred.
  • Familiarity with domestic and international regulatory requirements.
  • Experience in the preparation of clinical trial documentation for submission filing, including working knowledge of GCP and technical understanding of regulated products, biologics experience is preferred.
  • Demonstrated scientific and/or medical writing experience.
  • Able to work independently, prioritize, coordinate and complete multiple projects within deadline while maintaining high level of attention to detail.
  • Excellent problem solving skills and ability to work with minimal supervision.

 

Options

Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
Share on your newsfeed