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Post : Senior Specialist - Regulatory CMC
Job Description
• Ability to understand and support the development of regulatory CMC strategies and CMC dossiers i.e. Module 3, Module 2
• Comprehensive knowledge and Experience with developing regulatory CMC strategies and CMC dossier content requirements i.e. Module 3, Module 2.
• Experience in preparation and management of regulatory CMC documentation, including preferably international new product applications or variations.
• Experience with regulatory CMC life-cycle management activities would be an asset.
• Practical experience in one of the following area synthetic molecules and/or biotech molecules: manufacturing process development, transfers, validation or analytical development and quality management
• Awareness of global pharmaceutical legislation specifically linked to regulatory CMC aspects in the ICH countries.
• Excellent written and spoken communication skills in English (knowledge of other European languages is an asset such as German).
• Good interpersonal skills and flexible mindset.
• Attention to details.
• Ability to work in multinational teams.
• Awareness of Project management
• Awareness of regulatory CMC affairs contribution to Pharma business.
Additional Information
Job ID : 279980
Location : Bangalore – Electronic City
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Regulatory CMC
End Date : 20th December 2024
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