Merck Limited looking for Regulatory Affairs Senior Specialist

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 : Senior Specialist - Regulatory Affairs

Job Description
• To provide end-to-end support for Annual Reports and Renewals for all products, e.g. planning of required activities, attend kick-off/jour-fixe meetings, contribute to DSP and ensure timely collection of respective requirements and deliverables Update and review CMC specific documentation, incl. coordination with countries to compile local CMC variations.
• Conduct change control regulatory assessment for multiproduct site changes, incl., updating the CCP tracker, and performing required notifications.
• Management and responsibility of assigned CMC Regulatory activities and projects. Examples for these comprise answers to Health Authority queries, life cycle management submissions, marketing authorization applications wherever applicable.
• Accountable and responsible to provide country specific CMC regulatory requirements for dossier strategies and plans in close collaboration with other GRA functions. This includes assessment of Change Control Proposals for their regulatory impact worldwide to ensure that for each change control proposal, the regulatory implications have been considered.
• Accountable and responsible for global CMC-part of the regulatory strategy (RSD and DSP). This encompasses risk assessment, strategic support and advice.
• Review study protocols and reports, as well as other relevant technical documents intended for the product documentation platform or for local submission to confirm alignment of the report conclusions with the CMC Dossier Strategy and Plan.
• Accountable and responsible to confirm alignment between CMC dossier strategy and CMC regulatory documents before approval regarding fit to strategy, gaps, issues, risks and mitigation measures (within Dossier Generation Team).

Candidate Profile
• Degree in Pharmacy or Life Science, Medical, PharmD or related discipline (minimum M.Pharm or MSc or equivalent degree), higher degree preferable (e.g. PhD in a scientific discipline)
• Minimum of 7+ years of overall work experience in Pharma environment, Competent authority or Academia/R&D experience related to the role.
• Degree in Pharmacy or Life Science, Medical, PharmD or related discipline (minimum M. Pharm or MSc or equivalent degree), higher degree preferable (e.g. PhD in a scientific discipline)

Additional Information
Experience : 5+ years
Qualification : Degree in Pharmacy or Life Science, Medical, PharmD
Location : Bangalore, Karnataka
Industry Type : Pharma/ Healthcare/ Clinical research
End Date : 30th September 2025