Regulatory Affairs Associate

Highly Competitive Salary
  1. Permanent
  2. Officer /Associate, Project Manager, RA Intelligence
  3. United States
Rockville, USA
Posting date: 19 Aug 2020
RA.DS.31320
This vacancy has now expired

Proclinical is currently recruiting for a Regulatory Affairs Associate with a biopharmaceutical company located in Rockville, MD.

Job Responsibilities:

  • Analyst, Regulatory Policy and Intelligence RPI manages and maintains a variety of databases and communication platforms supporting RPI projects and services.
  • Conducts daily scanning of regulator websites for U.S. and Canada for regulatory intelligence and enters relevant information into RPI's regulatory intelligence platform.
  • Supports RPI approval trending analysis by entering appropriate information into databases.
  • Supports searches of regulatory intelligence sources to support senior RPI staff.
  • Prepares supporting material for RPI staff on regulatory policy topics.
  • Supports other regulatory intelligence activities as needed.
  • Creates and manages IT platforms to share information and manage RPI services and projects, e.g., Excel, SharePoint, Planner, Teams.
  • Develops and maintains templates for RPI materials to ensure consistency in information sharing within RPI and between RPI and other internal customers.
  • Manages the development and communication of regulatory policy newsletters and other relevant information.
  • Manages routine RPI meetings by supporting development of agenda, background materials, and meeting summaries.
  • Serves as back up office manager/administrative assistant.
  • Coordinates and provides support in implementing various RPI projects.

Skills and Requirements:

  • Required Education: High School diploma or equivalent and 4 years' experience or bachelor's degree.
  • Preferred Education: Bachelor's degree or Associate degree w/ at least 2 years of experience in a related role.
  • Required Experience: Strong command of SharePoint, Teams, Word, PowerPoint, and Excel. Demonstrated competency in distilling large amounts of information into concise executive summaries.
  • The incumbent should also be comfortable working in an environment where they can proactively bring forward new process and technology improvements for RPI services and communications.
  • Excellent communicator in written and verbal forms. Excellent organizational skills. Ability to work in a complex / matrix environment.
  • Preferred Experience: 2 years' experience in an industry related role; Experience in designing and implementing new processes/databases/platforms and creating appropriate communications based on distilled information.
  • Note: Higher education may compensate for years of experience and vice versa.

If you are having difficulty in applying or if you have any questions, please contact Dominic Santoro at 215-531-5280.

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

Proclinical Staffing is an equal opportunity employer.

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