Senior RA CMC Manager

At Proclinical, we are seeking an individual to fill the role of Senior RA, CMC Manager, based in Boston, MA. Reporting to VP, the head of Regulatory CMC, the successful candidate will provide support for Chemistry, Manufacturing and Controls (CMC) Regulatory Affairs for development and marketed small molecule and/or gene therapy products.

Responsibilities

• Prepare and review submission-ready CMC and marketing registration applications, supplements, amendments and variations.
• Provide CMC regulatory guidance for global development and registration programs.
• Assess and communicate CMC regulatory requirements to ensure development activities follow applicable regulations and guidelines.
• Primary regulatory representative at internal meetings as well as at meetings with regulatory agencies.
• Manage and ensure compliance with all reporting requirements, including annual and periodic reports.
• May manage contract staff and vendors as needed to support Regulatory activities.

Skills And Qualifications

• Degree in a scientific discipline with 5+ years regulatory experience, or BS with 5-7 years regulatory experience, OR PhD with 3+ years regulatory experience.
• Experience with preparing INDs, IMPDs, NDA and/or MAA submission(s) is essential.
• Working knowledge of regulatory guidelines and regulations (US and international).
• Regulatory experience supporting both development projects and marketed products.
• Prior hands-on experience with FDA CMC regulatory submissions.
• Strong knowledge of eCTD elements and structure and regulatory writing skills.
• Strong written, verbal, and interpersonal communication skills.

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 Tudor Carr at (+1) 6175455919 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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