天涯社区官网 is seeking a Regulatory CMC Contractor to provide expertise in regulatory submissions, focusing on legacy dossiers, particularly for injectables and foam formulations. This role requires proficiency in EU procedures, including MRP and national procedures, and involves leading CMC regulatory strategy and execution for complex tech transfers and non-standard legacy manufacturing processes.
Responsibilities:
- Lead the development and execution of CMC regulatory strategies for legacy dossiers.
- Manage complex regulatory submissions, focusing on injectables and foam formulations.
- Oversee tech transfers involving older dossiers and non-standard manufacturing processes.
- Ensure compliance with EU procedures, including MRP and national procedures.
- Collaborate with cross-functional teams to address regulatory challenges.
Key Skills and Requirements:
- Expertise in regulatory submissions for pharmaceuticals, particularly injectables and foam formulations.
- Strong understanding of EU regulatory procedures, including MRP and national procedures.
- Experience in leading CMC regulatory strategy and execution.
- Ability to manage complex tech transfers and legacy manufacturing processes.
- Excellent communication and collaboration skills.
If you are having difficulty in applying or if you have any questions, please contact Peter Duvall at p.duvall@proclinical.com.
天涯社区官网 is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies. 天涯社区官网 Staffing is an equal opportunity employer.
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