CMC Regulatory Affairs Manager
2 weeks ago
Position Overview:
We are seeking a qualified individual to take on the role of CMC Regulatory Affairs Manager within our esteemed organization, Katalyst HealthCares & Life Sciences. This position is crucial for the development of Chemistry, Manufacturing, and Control (CMC) documentation for our pharmaceutical products.
- Accountable for the preparation of CMC registration documentation under the supervision of CMC product leaders.
- Responsible for the creation and maintenance of regulatory CMC documents within our document management system.
- Tasked with developing technical CMC registration documents to ensure adherence to regulatory requirements across various jurisdictions.
- Lead the assembly of comprehensive Common Technical Document (CTD) Module and Quality Overall Summary (QOS) documents for regulatory submissions.
- Collaborate with project teams to assess change requests and ensure compliance with technical specifications.
- Update and manage technical registration dossiers for pharmaceutical products while remaining informed about industry standards.
- Work cross-functionally to resolve technical regulatory inquiries and prepare preliminary responses.
Qualifications:
- A Bachelor's or Master's degree accompanied by relevant professional experience.
- Expertise in developing and overseeing business processes.
- Familiarity with IT-based scientific systems and global CMC/Module development.
- Understanding of the US regulatory landscape and post-approval CMC modifications.
- Proficient in English; knowledge of German and/or French is advantageous.
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