PHARMAFull-time
Expert - Regulatory Labelling Operations
By Admin · Regulatory Affairs
BANGALORE (IN)ONSITEPOSTED: 10/3/2026
PHARMAFull-time
HIRING ORGANIZATIONMERCK KGAAPharmaceuticals and Life Sciences
ROLE OVERVIEW
The Expert - Regulatory Labelling Operations role focuses on global labeling operational excellence, process optimization, compliance tracking and continuous improvement within Regulatory Quality Safety (RQS).
ROLE DEFINITION & RESPONSIBILITIES
- •Support development, maintenance and review of global labeling policies, SOPs, work instructions and supporting documents
- •Coordinate labeling document updates, milestones and stakeholder inputs
- •Develop and maintain global labeling project plans and submission timelines
- •Track health authority interactions and labeling commitments
- •Monitor implementation of updated labeling and manage exceptions and deviations
- •Partner with Regulatory Quality Safety stakeholders on documentation, filing timelines and safety commitments
- •Identify and implement process improvements, digital solutions and technologies to improve labeling quality and operational efficiency
Reporting Hierarchy: Reports within the Regulatory Quality Safety (RQS) organization; Exact reporting manager and team size not specified in the supplied job description
* Role responsibilities and qualifications synthesized based on industry benchmark standards.
QUALIFICATIONS & REQUIREMENTS
REQUIRED QUALIFICATIONS
- 8-12 years of experience in Labeling Operations
- End-to-end labeling experience covering EU and US markets
- Strong project management skills
- Stakeholder management and influencing skills
- Experience in global, matrixed and cross-cultural environments
- Operational excellence and continuous improvement experience
PREFERRED QUALIFICATIONS
- •Knowledge of global labeling regulations and regulatory submission processes
- •Experience with labeling governance and commitment tracking
- •Experience with market implementation and compliance monitoring
- •Familiarity with change management, process mapping and performance metrics
- •Experience partnering with regulatory, safety, quality, medical, commercial and regional stakeholders
REQUIRED VERIFIED SKILLS
Regulatory labelling
global labelling operations
EU labelling
US labelling
regulatory submissions
health authority interactions
labeling governance
commitment tracking
compliance monitoring
SOPs
work instructions
project management
process improvement
change management
operational excellence
COMPENSATION & REWARDS
Salary: Competitive / Disclosed upon candidate shortlisting
Benefits: Professional development opportunities, inclusive workplace, learning and career-growth opportunities
No salary or bonus/equity information was disclosed in the supplied job posting; compensation should be confirmed directly with Merck KGaA.
ORGANIZATION CONTEXT & CULTURE
Merck KGaA is a global science and technology company operating across Healthcare, Life Science and Electronics, with a focus on innovation, scientific advancement and human progress.
TEAM SIZE: 60,000+ employees
INDUSTRY: Pharmaceuticals and Life Sciences
Culture: Global, diverse and inclusive environment emphasizing scientific innovation, operational excellence, collaboration, continuous improvement and employee development.
EXPECTED CAREER ROADMAP
Potential progression may include Global Labeling Excellence Lead, Regulatory Operations leadership and broader Regulatory Affairs or RQS operational-excellence responsibilities, depending on performance and organizational opportunities.
APPLICATION ADVISORY
Highlight 8-12 years of labeling operations experience; clearly demonstrate end-to-end EU and US labeling exposure; showcase global labeling governance, submission timelines and health-authority commitment tracking; emphasize project management and stakeholder influencing; provide measurable examples of process improvement, compliance and operational-excellence initiatives.
RECOMMENDED TRAINING
1/5
READY TO SUBMIT?
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