Regulatory Affairs Manager III

Proclinical is currently recruiting for a Regulatory Affairs Manager III for a biotechnology company located in Cambridge, MA.

Job Responsibilities:

• Prepare submissions (NDA/BLA or MAA) with combination product/medical device contents and oversight of development team; work on the combination product/medical device aspects (design controls).

Skills and Requirements:

• Regulatory Affairs, Biologic CMC and/or Combination Products and/or Medical Devices, drug delivery systems - specifically pre-filled syringes.
• Previous experience with coordinating or contributing to container closure & device global filing CTD content within M3 (US BLA & EU MAA), plus regulatory oversight experience with Design Controls including design verification & validation, human factors/usability studies, control strategies, and working with external suppliers.
• Experienced in technical/regulatory writing.
• Good communication skills and experience working cross-functionally and globally.
• Experience working with external suppliers, particularly for device components and container closure systems.
• Quick learner and able to navigate electronic systems to find information and apply to the given program.

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 Zachary Hines at 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.

Proclinical Staffing is an equal opportunity employer.

#LI-ZH1
#RegulatoryAffairs