Merck Limited Hiring Regulatory Affairs Manager

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 : Specialist - Regulatory Affairs Manager

Job Description
• The Specialist Regulatory Affairs Manager prepare dossiers and execute actions that support the license security and product compliance on the markets, and that meet company's and health authorities’ requirements.
• Encounter the challenges to enable representatives from all major disciplines involved to reach agreement on the licence management strategy and approach.
• Will be working in a matrix organization, with extensive communication and collaboration with stakeholders from various functions within or outside Global Regulatory Affairs.
• You will support the resolution of complex tasks, under close supervision and guidance provided from the more experienced License management personnel.

Candidate Profile
• Minimum 5 years of overall work experience in Pharma environment, Competent authority or Academia/R&D experience related to the role. Minimum 1 year of Regulatory affairs experience
• Degree in a Life Science or a related discipline, preferably MSc
• Experience in preparation and management of regulatory documentation, normally a full international submission (new product application) or large variations.
• Experience with life-cycle management activities in at least two regions (e.g. Europe, USA, International would be an asset).
• Good knowledge about Regulatory Affairs and specifically post approval changes, regulatory dossier types and main regulatory procedures globally.
• Understanding of supportive documents necessary for the registration and LCM of pharmaceutical products (CPPs, GMP Certificates, MLs, AtO’s, AFs, CLs, PoA’s etc.) as well as legalization framework.
• Ability to review and interpret country specific and international regulatory guidelines, policies and regulations to generate submission ready deliverables as per request.
• Adherence to agreed timelines and proactive communication of any potential risk to the same.
• Project management and documentation skills, proactive communication approach.
• Contributor level of experience with RIM and EDMS RA applications.

Additional Information
Experience : Minimum 5 years
Qualification : Degree in a Life Science
Location : Bangalore, Karnataka, India
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Regulatory Affairs
End Date : 10th November 2026