Regulatory Associate, CMC

Highly Competitive Salary
  1. Permanent
  2. Consultant / Specialist, CMC
  3. United States
Collegeville, USA
Posting date: 28 Aug 2020
RA.SB.31471

Proclinical is currently recruiting for a CMC Regulatory Associate with a global pharmaceutical company located in Collegeville, PA. As the CMC Regulatory Associate, you must have expert knowledge and hands-on experience in at least one area related to CMC biopharmaceutical product development (e.g. analytical or process development, manufacturing, quality control).

Skills and Requirements:

  • 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.
  • Recent hands on experience
  • Strong verbal communications skills and demonstrated ability to work in a matrix/team environment.
  • Ability to effectively plan, prioritize and co-ordinate multiple tasks and adjust to changing priorities to deliver results to tight deadlines.
  • Strong computer skills in Microsoft Office applications with the ability to learn new applications quickly and easily.
  • Two (2) or more years of CMC regulatory affairs experience with biopharmaceutical products (e.g., monoclonal antibodies and therapeutic proteins) preferred.
  • 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).

If you are having difficulty in applying or if you have any questions, please contact Sarah Beshara at (+1) 267-477-3355 or s.beshara@proclinical.com.

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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