REGULATORY ASSOCIATE - CMC

Proclinical is currently seeking a Regulatory Associate for a pharmaceutical company located in Collegeville, PA. Successful candidate will be responsible for preparing high quality, Chemistry, Manufacturing and Control (CMC) detailed regulatory documents using varied information sources.

Job Responsibilities:

• Liaising closely with other personnel to ensure accuracy of such records.
• Working to agreed deadlines and maintaining records to reflecting project status.
• Responsible for 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:

• 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.
• Two (2) or more years of CMC regulatory affairs experience with biopharmaceutical products (e.g., monoclonal antibodies and therapeutic proteins) preferred.
• 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).
• 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.
• Excellent oral and written communication skills.
• Knowledge of Electronic Document Management Systems, preferably Documentum, and publishing tools such as Adobe Acrobat.

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 at (+1) 267-477-3355 or upload your resume on our website - www.Proclinical.com.

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.

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