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Senior Specialist - Country Liaison, Operational Excellence

6+ years
₹13–20 LPA
10 July 28, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Senior Specialist – Country Liaison, Operational Excellence
Location: Bangalore, Karnataka, India
Job Type: Full-Time
Company: Merck Group


Role Overview:
Join Merck as a Senior Specialist – Country Liaison, Operational Excellence, where you will support global Regulatory Affairs (RA) projects, act as a liaison for regional initiatives, ensure compliance readiness, and contribute to operational excellence across regulatory systems. You will collaborate cross-functionally, drive data governance, and enable system enhancements for regulatory compliance and automation.


Key Responsibilities:

  • Support global regulatory initiatives and IT systems in coordination with RA stakeholders

  • Act as a Subject Matter Expert (SME) or Champion for regulatory training programs and system onboarding

  • Drive audit and inspection readiness at the country level

  • Align regional regulatory strategies for local product changes and submissions

  • Participate in data governance, including data cleansing and monitoring for AI readiness

  • Maintain regional regulatory documentation via RIMS local repositories

  • Serve as a key liaison between global regulatory affairs and therapeutic areas (TA)/RQS operations

  • Execute compliance-focused document review and support change impact assessments

  • Generate compliance reports and monitor data quality metrics

  • Lead activities aligned with VV processes and regulatory requirements


Qualifications:

  • Minimum 6 years of experience in Regulatory Affairs

  • Strong understanding of RA business processes and regulatory frameworks

  • Expertise in regulatory systems, documentation, and compliance operations

  • Excellent communication and stakeholder management skills

  • Skilled in process improvement, time management, and task prioritization

  • Capable of cross-functional collaboration in a global, fast-paced environment

  • High proficiency in English (verbal and written)

  • Strong analytical thinking, detail orientation, and team learning mindset

  • Ability to manage sensitive data and drive execution with measurable results


Estimated Salary: ₹13–20 LPA (based on senior regulatory roles in Bangalore)