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.

Job Responsibilities

• 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

To Apply

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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