Expert Regulatory Labeling Operations

3 days ago

Bengaluru, Karnataka, India The businesses of Merck KGaA, Darmstadt, Germany Full time

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:

Labeling Compliance Operations:

  • Safety Variation Compliance Monitoring, Presentation of Compliance results to the GRA Governance team.
  • Quarterly Safety variation KPI provision and presentation of safety variation compliance in GPS Compliance Review Board (chaired by the EU QPPV)
  • QC, Finalization and Delivery of PSMF Annex F2.3 A, B and C sub-annexes to the GPS  
  • Providing Inputs for Labeling Process Automation
  • Supporting PV and Labeling Audits and Inspections worldwide
  • Driving process improvement initiatives e.g. Veeva Breeze process optimization
  • Creation and Update of Labeling Quality Documents
  • Oversight of labeling Content Deviation and Artwork initiation compliance Check process
  • May also be required to support Labeling Strategy at peak times, as overall workload allows:
  • Labeling Product Lead for marketed product portfolio
  • Creates, updates and oversees implementation of Core labeling Documents
  • Coordinates Labeling Team discussion on key labeling topics
  • Provides labeling inputs for HA queries and PBRERs
  • Responsible for update and maintenance of MRP, DCP and CP product information.

Cooperation: Interfaces with other Departments/Functions:


 Internally:

Global Regulatory Affairs, Global Healthcare Operations, Global Regulatory Operations

Global Patient Safety and EU QPPV office and IT teams 

Externally: External Interfaces: Veeva and other IT vendors, Label Net Forums 

Who You are:

Education: MSc in Pharmaceutical Sciences or related discipline

Work Experience: 7-10 years of overall experience in Labeling Strategy and Operations

  • Attention to detail, excellent time management, project management, presentation and communication skills (written or oral), significant experience with VEEVA system and IT tools often used in regulatory departments in the pharmaceutical industry.
  • Good understanding of Global Labeling Compliance topics as well as various operational activities in global labeling departments of regulatory affairs.

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

Apply now and become a part of our diverse team

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