Job Title: Senior Specialist – Country Liaison, Operational Excellence
Job Summary
Join a global leader in life sciences as a Senior Specialist - Country Liaison, Operational Excellence at our Bangalore office. This exciting full-time role focuses on supporting and coordinating regulatory affairs projects, ensuring inspection readiness, managing regulatory information systems (RIMS), and driving compliance and data quality across international markets. Ideal for candidates with 6+ years in regulatory affairs and a passion for process excellence in the pharmaceutical sector.
Key Responsibilities
Coordinate and support multiple regulatory affairs projects and IT systems across regions.
Serve as Subject Matter Expert (SME) for training, documentation, and onboarding of new regulatory systems.
Manage country audit and inspection readiness activities.
Define and confirm regional regulatory strategies for local product changes.
Drive data cleansing, monitoring, and governance initiatives to support automation and AI systems.
Oversee document localization via RIMS local repositories.
Liaise with cross-functional teams to set regional regulatory approaches.
Act as an internal contact point for Therapeutic Areas (TAs) and RQS operations.
Lead initiatives in compliance and data governance, ensuring alignment with global regulatory standards.
Prepare compliance reports and monitor adherence to data quality benchmarks.
Required Skills & Qualifications
Bachelor's or advanced degree in life sciences, pharmacy, or a related field.
Minimum 6 years of experience in regulatory affairs, preferably in the pharmaceutical sector.
Expertise in regulatory processes, RIMS systems, and global compliance standards.
Strong knowledge of regulatory IT systems and data governance frameworks.
Excellent project management, time management, and problem-solving skills.
Effective verbal and written communication skills in English.
Ability to manage multiple priorities in a fast-paced, dynamic environment.
Proactive mindset with a focus on continuous improvement and operational excellence.
Perks & Benefits
Inclusive and diverse work environment.
Opportunities for global collaboration and cross-functional learning.
Professional development programs and growth opportunities.
Exposure to cutting-edge regulatory systems and AI-driven tools.
Supportive leadership committed to work-life balance.
Company Description
As a global leader in healthcare, life sciences, and electronics, MilliporeSigma (part of Merck KGaA, Darmstadt, Germany) empowers innovation through scientific and technological excellence. Our focus on regulatory excellence, safety, and operational leadership sets industry standards worldwide.
Work Mode
On-site (Bangalore, India)
Salary/Compensation
Not specified in the job description.
Call to Action
Ready to elevate your career in regulatory affairs with a world-class life sciences leader? Apply now for the Senior Specialist - Country Liaison, Operational Excellence role and become part of a team driving global healthcare innovation.
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