Belcan CMC Manager in Morristown, New Jersey
Job Number: 211980
Category: A - Immediate/Urgent Need
Our client in Morristown, NJ has an immediate need for a CMC Manager!
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
• 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
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...)
Return to search results Email this job to a friend
If you have previously registered with us, pleaseLog into apply for this position.
*Logged in members may also add jobs to their job cart