Expert - Regulatory Labelling operations

Merck Healthcare; Bengaluru; On-site; INR 1,800,000 - 2,400,000; Full time

Job summary

Merck Healthcare in Bengaluru seeks a Global Labeling Excellence Lead to drive operational excellence in global labeling within Regulatory Quality Safety. You will partner with process owners and cross-functional teams to implement compliant, scalable labeling processes that align with regulatory expectations.

You will apply continuous improvement methods to strengthen documentation, track milestones, and deliver practical recommendations that enhance labeling quality, compliance, and efficiency

Qualifications

• 8–12 years of experience in labeling operations.
• End-to-End labeling experience (EU/US).
• Strong project management with cross-functional stakeholder engagement.
• Experience with process improvement and operational excellence initiatives.
• Experience maintaining labeling documentation, SOPs, and work instructions.

Responsibilities

• Lead global labeling initiatives to advance operational excellence within Regulatory Quality Safety (RQS).
• Partner with process owners and cross-functional stakeholders to implement compliant, scalable labeling processes.
• Apply continuous improvement methodologies to improve ways of working and documentation practices.
• Develop and maintain labeling project plans, submission timelines, and health authority interaction tracking.
• Monitor labeling implementations, manage deviations, and track compliance metrics for timely submissions.

Skills

Project management

Stakeholder engagement

Continuous improvement

Documentation control

Global labeling

Job description

Work Your Magic with us! Ready to explore, break barriers, and discover more? We know you've got big plans - so do we! 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. 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.
• 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.

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.
• Coordinate and track labeling document updates, internal milestones, and stakeholder inputs to support timely execution and alignment across global and regional teams.
• 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.
• Monitor implementation of new and updated labeling in markets, manage exceptions and deviations, and track compliance metrics to support on-time submissions and implementation.
• 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.
• Experience working in matrixed, global organizations and partnering with regulatory, safety, quality, medical, commercial, and regional stakeholders.

What we offer:

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!