Specialist - Regulatory Affairs - Operations 4A

Specialist - Regulatory Affairs - Operations

Ready to turn bold ideas into real-world impact?
 At Genpact, we don’t just adapt to change, we lead it. AI and digital innovation are transforming the way businesses work, and we’re at the forefront of it. Genpact’s AI Gigafactory, our industry-first accelerator, exemplifies how we scale advanced technology solutions to help global enterprises work smarter, grow faster, and transform at scale. Whether tackling complex challenges through large-scale models or agentic AI, our breakthrough solutions tackle companies’ most complex challenges.
 
If you thrive in a fast-moving, innovation-driven environment, love building and deploying cutting-edge AI solutions, and want to push the boundaries of what’s possible, this is your moment. 
 
Genpact (NYSE: G) is an agentic and advanced technology solutions company. We leverage process intelligence and artificial intelligence to deliver measurable outcomes. With a strong partner ecosystem and decades of client trust, we provide innovative solutions that transform how businesses run. Powered by a team with an active learning mindset and client centricity at its core, we deliver lasting value for the world’s leading enterprises.
 Get to know us at genpact.com and on LinkedIn, YouTube, X, and Facebook.

Job Description -

Data Remediation/Regulatory Master Data Management

Responsibilities

• Data Analyst
  • Handling of Master Data Entries in all relevant systems according to Data Governance Rules and Business needs
  • Provides hands‑on data remediation expertise to correct, standardize, and stabilize regulatory
  • Provides recommendations to align with the Veeva data model, including data definitions, structures, relationships, and dependencies.
  • Performs detailed data analysis and validation, identifying data quality issues, root causes, and remediation actions.
  • Applies strong knowledge of data governance principles, ensuring alignment to defined standards, controlled vocabularies, and business rules.
  • Supports regulatory and RIM teams by translating business and compliance requirements into accurate data corrections.
  • Works closely with RIM, Regulatory Operations, and Data Operations to execute remediation activities in a controlled and compliant manner.
  • Demonstrates strong analytical capability using Excel and related tools to manage large datasets and remediation trackers.
  • Operates in a hands‑on, execution‑focused role, ensuring timely and high‑quality remediation outcomes.
  • Preparation of IDMP changes/entries in all relevant systems

 

PROJECT DELIVERABLES/SCOPE OF WORK

Ø  Data Remediation/ Regulatory Master Data Management

• • Regulatory Master Data Entries according to internal process including necessary investigations for correct and complete data entry and contact to data owner and business
  • Remediated, high‑quality regulatory data aligned to Veeva data model standards and European regulatory requirements.
  • Documented remediation actions and traceability, supporting audit and inspection readiness.
  • Data quality reports and metrics highlighting issues resolved, remaining risks, and trends.
  • Consistent application of data definitions and structures across impacted records and markets.
  • Validated datasets ready for downstream regulatory processes, submissions, and reporting.
  • Reduced data inconsistency and rework through accurate, first‑time remediation.
  • Effective collaboration with cross‑functional teams to ensure clear handoffs and issue resolution.

Sustained data governance compliance, supporting long‑term data stability post‑remediation.

Qualifications -

Bachelors - Health Administration, Bachelors - Healthcare, Bachelors - Pharmacy, Masters - Public Health, Masters - Regulatory Affairs

Certifications -

Certified Compliance Officer (CCO) - VskillsVskills, Certified Public Accountant (CPA) - Perfekt SzolnokPerfekt Szolnok, Certified Regulatory and Compliance Professional (CRCP) - JSS UniversityJSS University, Certified Regulatory Compliance Manager (CRCM) - The International Association of Risk and Compliance Professionals (IARCP)The International Association of Risk and Compliance Professionals (IARCP)

Required Skills -

Data Remediation

Language

English (Required)

Language Proficiency -

Proficient - C2

Additional Job Location -

Job Type

Regular

Master Skill List -

Regulatory Affairs - Operations

Remote Type -

Remote

Work Shift -

Standard (Germany)

Why join Genpact?
•    Lead AI-powered transformation – Drive innovation and solve real-world business challenges that matter
•    Make an impact – Help global enterprises solve business challenges that matter 
•    Accelerate your career – Gain hands-on experience, mentorship, and world-class learning opportunities to stay ahead
•    Work with the best – Join 140,000+ bold thinkers and problem-solvers who push boundaries every day 
•    Thrive in a values-driven culture – Our courage, curiosity, and incisiveness - built on a foundation of integrity and inclusion - allow your ideas to fuel progress 
 
Come join the 140,000+ coders, tech shapers, and growth makers at Genpact and take your career in the only direction that matters: Up.  
Let’s build tomorrow together. 
 
Genpact is an Equal Opportunity Employer and considers applicants for all positions without regard to race, color, religion or belief, 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 and integrity, customer focus, and innovation.  
Furthermore, please do note that Genpact does not charge fees to process job applications and applicants are not required to pay to participate in our hiring process in any other way. Examples of such scams include purchasing a 'starter kit,' paying to apply, or purchasing equipment or training.