Merck Limited (formerly E. Merck Limited) was set up in India as the first Merck subsidiary in Asia in 1967. The Company operates both its Pharmaceuticals and Chemicals businesses in the country. Merck was also the first Merck Group Company to go public in the year 1981. The Merck Group now holds 51% of the share capital in Merck Limited, while the remaining 49% is traded on the Bombay Stock Exchange Ltd.
Post : Expert Regulatory CMC
Job Description
• Support and implement CMC Regulatory Intelligence activities (NB this is a non-product specific role):
• Databases (e.g., CMC Regulatory Country Requirements, Life Cycle Management/Investigational Medicinal Product Catalogues, Wiki-handbook) maintenance and their continuous improvement (including liaison with external data providers, as appropriate).
• Active participation in Change Control Process meetings, Chair of Quality Regulatory Assessment Committee (QRAC) meetings and monthly updates sessions, author/co-author of Position Papers and responses to Reg CMC queries, SME for guidelines revision, etc.).
• Ensure alignment between CMC Regulatory Intelligence and GRA CMC & Device teams (e.g., by improving interoperability, agility, engagement and cohesion).
• Deliver, from a non-product specific perspective, on small molecules, large molecules, medical devices (i.e., drug-device combinations) with regards to marketed post-approval activities as per CMC Regulatory Intelligence Road maps.
• Participation in Trade Association calls in listening & learning/observer mode by leveraging the discussion and lessons learnt onto CMC Regulatory Intelligence databases.
• Provide support on digitalization projects.
• Effective utilization of Veeva system for all the CMC regulatory activities.
Candidate Profile
• Degree in a Life Science, Medical, PharmD or related discipline (minimum MSc or equivalent degree). Higher degree preferable (e.g. PhD in a scientific discipline) or education in Regulatory Affairs.
• 10 years of overall work experience (e.g. generated in Pharma environment, Competent authority, Academia, R&D, Consultancy) related and applicable to this CMC Regulatory Intelligence role. Minimum 5 years of Global CMC regulatory experience.
Additional Information
Experience : 10 years
Qualification : Degree in a Life Science, Medical, PharmD
Location : Bangalore, Karnataka
Industry Type : Pharma/ Healthcare/ Clinical research
Job ID : 291455
End Date : 30th September, 2025
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