MSI Pharma are looking to hire a CMC Manager - Gene Therapy for a US based pharmaceutical firm. This is a contract role and can be worked fully remotely from anywhere in the USA.
In this role you will:
- Review CMC information for CTAs, INDs and other regulatory submissions related to product development (e.g. CMC documentation for Scientific Advice Meetings, Briefing Books, IBs).
- Prepare, revise and review Module 2.3, Module 3, equipment information and related documents for new product registrations (e.g. MAAs, BLAs). This may include technical authoring of dossier narratives and other regulatory CMC documentation.
- Prepare and review CMC related information and documentation required for tenders, PSURs, DSURs, CCDS/product information and promotional materials.
- Represent Global Regulatory Affairs in Project Strategy Teams for CMC projects and/or cross functional sub-teams.
- Evaluates the available technical and scientific CMC information for compliance with regulatory requirements, performs gap analysis and proposes solutions and strategies to reduce risks.
- Supports scheduling and prioritization of CMC related submissions.
You must have:
- Experience in performing CMC compliance activities
- Fluent English oral and written communication skills
- Bachelor's or master's degree required in science, engineering or related field (advanced degree preferred)
- 6-10 years experience in the Pharmaceutical Regulatory Industry/ CMC
- Proven and relevant regulatory affairs experience in pharmaceutical / Gene Therapy
If you are interested then please apply now! If you would like more information then email us or call +44 (0)203 789 2061. We look forward to your application.
