Belcan CMC Manager in Morristown, New Jersey

CMC Manager

Job Number: 211980

Category: A - Immediate/Urgent Need

Description:

Our client in Morristown, NJ has an immediate need for a CMC Manager!

Job purpose

This position will support the Morristown CMCD team. The CMCD team is responsible for providing technical leadership to ensure compliance in the development of Chemistry, Manufacturing and Control (Module 3) technical documentation for the company’s commercial products.

The job purpose is to prepare technical CMC registration documents in order to maintain the existing marketing authorization (i.e. dossier updates, variations, renewals, response to deficiency letters, compliance gap closures) in various countries where the company is doing business.

Duties and responsibilities:

  • Draft or update the technical registration dossiers (CTD Module III and QOS or equivalent) of pharmaceutical products

  • Evaluate change requests with a goal of defining technical requirements according to guidelines

  • Work with manufacturing sites and contract sites to ensure the on-time compilation of high quality CTD Module III documents

  • Evaluate and manage the Technical CMC dossier documentation involved in change requests (including manufacturing site transfers) of pharmaceutical products

  • Discuss and align with customers on the regulatory strategy for maintenance activities

  • Maintain knowledge of current industry requirements and standards for CTD Module III and post-approval activities

  • Represent CMCD team in cross functional project, process and /or infrastructure teams as required

  • Coordinate the preparation of draft responses to technical-regulatory questions from health authorities including writing of expert statements and scientific justifications

Requirements:

Qualifications

Requirements:

• Degree in the sciences (chemistry, biology, etc.)

• Ability to understand technical reports (stability, validation, manufacturing)

• Experience in authoring submissions (variations, supplements, annual reports)

• Understand change controls and dossier maintenance

• Experience in post-approval maintenance of products

• Detail-oriented

Immediate long-term contract opportunity with an outstanding client! Please send resume, references, and salary requirements to be considered.

Belcan is a leading provider of qualified personnel to many of the world's most respected enterprises. We offer excellent opportunities for contract/temporary, temp-to-hire, and direct assignments in the technical, IT, professional, clerical, and light industrial fields. We are the employer of choice for thousands worldwide. Our overriding goal is to provide quality staffing solutions that help people, organizations, and communities succeed. Belcan is a team-driven Equal Opportunity Employer committed to workforce diversity. For more information, please visit our website athttp://www.belcan.com.

Location: Morristown , NJ

Minimum Experience (yrs): 5

Required Education: Bachelor (BA, BS...)

Benefits:

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