Regulatory Associate

Highly Competitive
  1. Contract
  2. CMC
  3. United States
Collegeville, Pennsylvania
Posting date: 05 Feb 2019

ProClinical is advertising an exciting opportunity for a Regulatory Associate position with a pharmaceutical company in Pennsylvania. Our client is a top 10 global pharmaceutical company, with leading products across various therapeutic areas. This is a contract position.

Job Responsibilities:

  • Preparing high quality Chemistry, Manufacturing and Control (CMC) detailed regulatory documents using varied information sources.
  • Liaising closely with other personnel to ensure record accuracy.
  • Working to agreed deadlines and maintaining records to reflecting project status.
  • Highlighting potential delaying factors promptly to line management and sharing knowledge of regulatory documentation and procedures with others to assist in problem solving.
  • Proactively pursuing process improvement and sharing of best practice.

Skills and Requirements:

  • A bachelor's degree in life sciences or related scientific discipline.
  • Experience in authoring CMC content for regulatory submissions, preferably with a minimum of 2 years in regulatory affairs or related function.
  • Strong technical writing skills and attention to detail.
  • Strong verbal communications skills, and a demonstrable ability to work in a matrix/team environment.
  • An ability to effectively plan, prioritise, and co-ordinate multiple tasks and adjust to changing priorities to deliver results to tight deadlines.
  • At least 2 years of CMC regulatory affairs experience with biopharmaceutical products.
  • A thorough knowledge of Electronic Document Management Systems, preferably Documentum, and publishing tools such as Adobe Acrobat.
  • Expert knowledge and hands-on experience in at least one area related to CMC biopharma product development.

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 Sarah Beshara on + 267-477-3355 or upload your CV on our website -

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.