Expert - Regulatory Labelling operations

Role overview

Expert - Regulatory Labelling operations at Merck

Responsibilities

• Work Your Magic with us!
• Coordinate and track labeling document updates, internal milestones, and stakeholder inputs to support timely execution and alignment across global and regional teams.
• Monitor implementation of new and updated labeling in markets, manage exceptions and deviations, and track compliance metrics to support on-time submissions and implementation.

Employment details

• Location: Bangalore [Karnataka] [India]

Application details

• As the successful GLE Lead, you will apply established continuous improvement and change-management methodologies to improve ways of working, strengthen documentation and tracking practices, and provide practical recommendations that enhance global labeling quality, compliance, and operational effectiveness.

Benefits

• Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics.
• Experience working in matrixed, global organizations and partnering with regulatory, safety, quality, medical, commercial, and regional stakeholders.
• We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences.
• We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology.
• We are committed to creating access and opportunities for all to develop and grow at your own pace.
• Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
• Apply now and become a part of our diverse team!

Additional role details

• Ready to explore, break barriers, and discover more?
• We know you’ve got big plans – so do we!
• Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet.
• That`s why we are always looking for curious minds that see themselves imagining the unimageable with us.
• Your Role.
• The Global Labeling Excellence Lead is responsible for advancing operational excellence, process optimization, and continuous improvement across global labeling activities within Regulatory Quality Safety (RQS).
• This role partners closely with process owners and cross-functional stakeholders to assess, implement, and monitor efficient, compliant, and scalable labeling processes that support business priorities and regulatory expectations.
• Who You are. 8 – 12 Years of experience in Labeling Operations.
• End to End Labelling experience (EU/US).
• Strong project management skills, including stakeholder management and ability to demonstrate collaborative stakeholder engagement and influencing skills across a globally, matrix, cross-cultured environment.
• Operational excellence and continuous improvement mindset; experience contributing to cross-functional initiatives, process improvement efforts, or operational excellence projects.
• Support the development, maintenance, and review of documentation related to global labeling processes, including policies, standard operating procedures, work instructions, and supporting documents.
• Develop and maintain global labeling project plans, submission timelines, and health authority interaction tracking to ensure commitments and deliverables are visible, current, and effectively. managed.
• Establish and oversee a comprehensive global labeling commitment tracker to promote timely follow-through, accountability, and alignment with regulatory expectations and required timelines.
• Partner with cross-functional RQS stakeholders on quality documentation, filing timelines, safety-related commitments, and related operational deliverables.
• Identify and implement process improvements, digital solutions, and new technologies that simplify work, improve labeling quality, and increase operational efficiency.
• Preferred Requirements.
• Knowledge of global labeling regulations, regulatory submission processes, and health authority expectations.
• Experience supporting labeling governance, commitment tracking, market implementation, or compliance monitoring activities.
• Familiarity with change management, continuous improvement, process mapping, metrics, or operational performance tracking.