Specialist Country Liaison, Operational Excellence

6 days ago

bangalore, India The businesses of Merck KGaA, Darmstadt, Germany Full time

Your Role: The Country Liaison Specialist supports regulatory operational activities for international markets. The role focuses on coordinating post approval submissions, managing data and documentation in regulatory systems, and ensuring smooth interaction between regional and local regulatory teams.Who You Are: A regulatory professional with strong execution capability, attention to detail, and the ability to collaborate in a global environment.Basic/ Minimum Qualifications: University degree in pharmaceutical sciences or equivalent.1–5 years of experience in regulatory affairs and/or project management.Relevant 3+ years' experience in Regulatory Affairs.Understanding of regulatory business processes and submission activities.Experience with Veeva Vault RIM or similar regulatory systems.Strong analytical skills and ability to interpret data.Ability to prioritize tasks in a fast‑paced environment.Experience in process improvement, data quality, or automation initiatives.Ability to create structured work schedules and manage timelines effectively.Preferred Qualifications: Experience with Veeva Vault RIM and automationSupport and coordinate post‑approval changes, renewals, and maintenance submissions.Assist in CMC variation preparation aligned with country requirements.Support regulatory documentation readiness for Health Authority submissions.Support artwork, safety and labelling workflows.Contribute to audit/inspection preparation.Stay updated on regulatory intelligence and apply it to daily tasks.Work with regulatory systems such as Veeva Vault RIM, WebCenter, and local repositories.Ensure timely and accurate data updates in global RA systems.Support training documentation and onboarding for new system users.Drive data governance and cleansing initiatives supporting automation and digital compliance.Act as SPOC for assigned regions and coordinate communication between International RA and local RA teams.Participate in cluster‑specific working models.

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