Specialist - Regulatory Affairs - Operations 4B

Specialist – Regulatory Affairs – Operations 4B – Genpact Deutschland GmbH, Munich

This full‑time, on‑site position focuses on regulatory master data management and data remediation within Genpact’s operations. The role requires a strong background in data governance, regulatory compliance, and analytical tools to ensure high‑quality data for downstream regulatory processes.

• Handle master data entries in all relevant systems in accordance with data governance rules and business needs.
• Provide hands‑on remediation expertise to correct, standardize, and stabilize regulatory data.
• Recommend alignment with the Veeva data model, including data definitions, structures, relationships, and dependencies.
• Perform detailed data analysis and validation, identifying data quality issues, root causes, and remediation actions.
• Apply data governance principles to ensure adherence to standards, controlled vocabularies, and business rules.
• Translate business and compliance requirements into accurate data corrections for regulatory and RIM teams.
• Collaborate with RIM, Regulatory Operations, and Data Operations to execute remediation activities in a controlled and compliant manner.
• Use Excel and related tools to manage large datasets and remediation trackers with strong analytical capability.
• Maintain a hands‑on, execution‑focused approach to deliver timely, high‑quality remediation outcomes.
• Prepare IDMP changes and entries in all relevant systems.

• Bachelor’s degree in Health Administration, Healthcare, or Pharmacy.
• Master’s degree in Public Health or Regulatory Affairs.
• Certified Compliance Officer (CCO) – Vskills.
• Certified Public Accountant (CPA) – Perfekt Szolnok.
• Certified Regulatory and Compliance Professional (CRCP) – JSS University.
• Certified Regulatory Compliance Manager (CRCM) – The International Association of Risk and Compliance Professionals (IARCP).
• Strong client relations and data analytics skills.
• English required; advanced proficiency (C1) mandatory.

• Location:
  
  Munich, Germany
• Type:
  Fixed Term (end date 31 July 2027)
• Remote:
  Hybrid
• Work shift:
  
  Standard (Germany)
• Shift hours: 8:00‑17:00 CET
• Work environment:
  On‑site, standard office

Genpact is an Equal Opportunity Employer and considers applicants for all positions without regard to race, color, religion, sex, age, national origin, citizenship status, marital status, military/veteran status, genetic information, sexual orientation, gender identity, physical or mental disability, or any other characteristic protected by applicable laws. Genpact is committed to creating a dynamic work environment that values respect, integrity, customer focus, and innovation.