Merck KGaA
Senior Specialist - Regulatory CMC
Job Description
Title: Senior Specialist – Regulatory CMCLocation: Bangalore – Electronic City Job Specific Competencies & Skills:Ability to understand and support the development of regulatory CMC strategies and CMC dossiers i.e. Module 3, Module 2Comprehensive 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 managementAwareness 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 managementAwareness of regulatory CMC affairs contribution to Pharma business. We are an equal opportunity employer that values workforce diversity. We want everyone to be able to bring their best self to work every day which is why equality and inclusion is at the forefront of all our activities. We are dedicated to a policy of non-discrimination in employment on any basis including race, caste, creed, color, religion, sex, age, disability, marital status, sexual orientation, and gender identity.
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