CMC Manager
Title: CMC Manager
Location: 36 Columbia Rd., Morristown, NJ, USA, 07962
Duration: 12+ Months
Job Description:
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 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 is doing business.
The primary job duties and responsibilities include the following.
- 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:
- 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.
Additional Information
Thanks & Regards,
Ankit Tyagi
Clinical/Pharma Recruiter
Tel: (408)-963-0070