Regulatory Associate - CMC

Highly Competitive
  1. Permanent
  2. Officer /Associate, CMC
  3. United States
Collegeville, Pennsylvania
Posting date: 29 Mar 2019

ProClinical is partnering with a well known global pharmaceutical company with leading products across various therapeutic areas to advertise a vacancy for a Regulatory Associate - CMC. Based with the company's Pennsylvania team, this is an exciting opportunity to work at a top 10 global pharmaceutical company that employs approximately 100,000 people worldwide.

Job Responsibilities:

  • Preparing high quality, Chemistry, manufacturing, and control (CMC) detailed regulatory documents using varied information sources.
  • Liaising closely with other GSK personnel to ensure accuracy of such records.
  • 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.

To Apply:

  • 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.
  • At least 2 more years of CMC regulatory affairs experience with biopharmaceutical products (e.g., monoclonal antibodies and therapeutic proteins) preferred.
  • Strong technical writing skills and attention to detail.
  • 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 biopharm product development (e.g. analytical or process development, manufacturing, quality control).
  • Demonstrable multitasking, project management, and execution skills.
  • Good interpersonal skills, including communication, presentation, persuasion, and influence.
  • Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
  • Proficiency with computer skills, such as MS Office.

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 contact Sarah Beshara at + 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.