Expert Regulatory Labeling Operations
Company: Merck KGaA
Location: Bangalore, Karnataka, India
Job Type: Full-Time
Department: Global Regulatory Affairs
Job Overview
Merck KGaA is seeking an Expert Regulatory Labeling Operations professional to manage global labeling compliance, safety variation monitoring, and regulatory labeling processes within Global Regulatory Affairs. This role supports global pharmacovigilance and regulatory teams by ensuring compliance with international labeling requirements, maintaining regulatory documentation, and driving process improvements across labeling operations.
The position involves cross-functional collaboration with global regulatory, patient safety, and IT teams to ensure accurate product labeling, regulatory compliance, and efficient operational processes supporting marketed product portfolios worldwide.
Key Responsibilities
Manage safety variation compliance monitoring activities and present compliance outcomes to governance teams.
Provide quarterly safety variation compliance reports and key performance indicators to regulatory governance boards.
Perform quality control, finalization, and delivery of Pharmacovigilance System Master File (PSMF) annex documentation.
Support pharmacovigilance and labeling audits and inspections across global markets.
Drive process improvement initiatives related to labeling operations, including optimization of digital regulatory systems and workflows.
Develop, update, and maintain labeling quality documents and regulatory procedures.
Ensure compliance in labeling content deviation processes and artwork initiation activities.
Provide input and support for labeling process automation initiatives.
Support labeling strategy activities during peak workload periods, including managing labeling activities for marketed product portfolios.
Create, update, and oversee implementation of core labeling documents in alignment with global regulatory requirements.
Coordinate cross-functional labeling discussions and provide labeling inputs for health authority queries and periodic safety reports.
Maintain product information documentation across regulatory procedures such as MRP, DCP, and CP.
Collaborate with internal departments including Global Regulatory Affairs, Global Healthcare Operations, Global Regulatory Operations, Global Patient Safety teams, and EU QPPV office.
Engage with external stakeholders including IT vendors and regulatory industry forums to support operational excellence.
Education Requirements
Master’s degree in Pharmaceutical Sciences or a related scientific discipline.
Experience Required
7–10 years of professional experience in regulatory labeling strategy and operations within the pharmaceutical or life sciences industry.
Demonstrated experience in global labeling compliance, pharmacovigilance-related labeling activities, and regulatory documentation management.
Experience working with regulatory IT platforms such as Veeva systems and other regulatory information management tools.
Strong understanding of global labeling regulations and operational processes within regulatory affairs functions.
Core Skills and Competencies
Strong knowledge of global regulatory labeling compliance and pharmacovigilance requirements.
High attention to detail with strong quality and compliance orientation.
Excellent project management and time management skills.
Strong presentation and communication skills, both written and verbal.
Ability to manage complex regulatory processes and multiple priorities in a global environment.
Experience with digital regulatory systems and process automation initiatives.
Strong collaboration and stakeholder engagement capabilities in cross-functional teams.
Work Environment and Career Growth
This role provides the opportunity to work in a global regulatory environment focused on compliance excellence, operational innovation, and continuous improvement. The organization offers a collaborative culture, international exposure, and strong career development opportunities within regulatory affairs and pharmacovigilance operations.
Diversity and Equal Opportunity
The organization is committed to fostering a diverse and inclusive workplace and provides equal employment opportunities to all employees and applicants in accordance with applicable laws and regulations.
About the Organization
Merck KGaA is a global science and technology company operating across healthcare, life sciences, and electronics sectors. The organization focuses on advancing scientific innovation and improving patient outcomes through research-driven solutions and global collaboration.
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