The Merck Group, branded and commonly known as Merck, is a German multinational science and technology company headquartered in Darmstadt, with about 60,000 employees and a presence in 66 countries. The group includes around 250 companies; the main company is Merck KGaA in Germany.
Post : Associate 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
Candidate Profile
Degree in a Life Science or related discipline (minimum MSc or equivalent degree), higher degree preferable (e.g. PhD in a scientific discipline)
Requires a graduate background plus some to substantial relevant professional experience, and good knowledge and experience in own discipline and beyond. Minimum 1-3 years of pharmaceutical industry experience
Additional Information
Experience : 1-3 years
Qualification : Degree in a Life Science
Location : Bangalore
Industry Type : Pharma/ Healthcare/ Clinical research
End Date : 30th October, 2023
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