Regulatory CMC Manager
Proclinical are currently looking for a Junior Regulatory Manager to join an established pharmaceutical in Basel. This is a 12 month contract role with the opportunity to extend if needed.
- Experience in writing / authoring of CMC documentation for submission to HA. Ensuring you are applying agreed CMC global regulatory strategies, assuring technical alignment and regulatory compliance, meeting with agreed timelines throughout project lifecycle.
- Prepare CMC Q&A responses to HA question sessions during development, registration and product lifecycle.
- Identify the required documentation for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines.
- Identify content, quality and/or timeliness issues with source documents, or any other potential authoring issues that may impact submission quality or timelines, as early as possible.
- Keep knowledge up to date with regard to regulatory guidelines and requirements in all global regions as well as for new technical trends.
- Actively participate as a member of the global team by contributing to the regulatory strategy, identifying the critical issues and lessons learned.
- Establish and maintain sound working relationships with partners and customers.
- Assume activities in support of the general department such as DRAGON support, annual and product renewal writing, coordination/collection/storage of source documentation needed for direct submission to HAs, other database entry activities (specialised department functions).
Skills and Requirements
- Must have significant experience in regulatory affairs and an extensive knowledge of regulatory requirements, including ICH requirements and regional requirements
- Must be capable of the preparation and finalization of CMC regulatory dossiers and managing the ongoing maintenance of existing product licenses
- Well versed and competent with regulatory documentation and submission management systems
- Excellent verbal, written and interpersonal communication skills are required
- Must have excellent organizational skills and an ability to work on several projects with tight timelines
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.