Sr. Specialist - Regulatory Affairs - Operations 4C

Sr. Specialist - Regulatory Affairs - Operations

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Job Description

Sr. Specialist (Band 4C), Data Support End User Expert – Veeva RIM

The Sr. Specialist, Data Support End User Expert, is responsible for overseeing global regulatory master data management operations, ensuring data quality, compliance, and adherence to MDM standards within RIM systems. The role leads and supports the data management team, drives process improvements, manages client relationships and governance activities, and develops reporting metrics to ensure timely, accurate, and high-quality service delivery. Leveraging expertise in Regulatory Affairs systems, data governance, reporting, and Six Sigma methodologies, the individual enables operational excellence and continuous improvement across regulatory data management processes.

Support Veeva Active Dossier Management by performing:

• Dossier Lifecycle Oversight: Maintain a holistic, cross-market view of current, submitted, and superseded product documents using Veeva Vault Active Dossier.

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• Data & Process Automation: Oversee automated generation and calculation of dossier records linked to regional submissions, global content plans, and health authority interactions

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• Configuration & Maintenance: Manage Active Dossier templates, object lifecycles, and country-level generation rules within Veeva Vault.

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• Cross-Functional Support: Partner with regulatory authors, CMC teams, and submission managers to verify traceability and resolve document-type discrepancies.

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• Audit & Compliance Readiness: Ensure accurate tracking of local-language translations, source files, and status history across various international markets.

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Key Responsibilities:

· Responsible for guiding the entry, updating, maintenance, and archival of data entry/correction requests from RIM system users globally

· Helps establish MDM standards to enable the transfer of information from data entry request forms into the established systems

· Ensures sustained data quality

· Acts as the liaison to client management for all process-related items

· Escalates issues and concerns from team members

· Conveys feedback from the client to team members

· Responsible for establishing and providing oversight to the data management team, ensuring that:

• Team members are trained appropriately and understand their roles

• Service levels are met

• All deliverables are produced according to the process and within the agreed timelines

· Assist in identifying process improvement areas

· Participates in governance meetings with the client regularly

Works with the client to develop a clear and detailed plan for reporting metrics

Required Skills & Experience:

· Experience in developing and maintaining master data management standards for regulatory systems

· Ability to handle transactions in line with the established procedures and policies

· Ability to handle project operations

· Ability to protect confidential information

· Strong capacity to work within deadlines

· Ability to perform the assigned tasks swiftly and accurately

· Detail oriented

· Outstanding skills in customer service delivery

· Demonstrated problem-solving skills

· Proven experience in analyzing information in support of data management activities

· Managing processes and ensuring staff compliance

· Experience in Six Sigma methodology

· Experience in supporting and working with tools and systems used in the Regulatory Affairs environment

· Developing standards

· Reporting skills

· Expertise in regulatory and data reporting systems and MS Excel

Key Requirements:

• Experience in pharmaceutical, biotechnology, or medical device organizations operating globally. Bachelor’s degree required.

• Experience leading data governance, master data management, process improvement, or transformation initiatives.
• Familiarity with reporting, analytics, and data visualization tools.
• 10+ years in regulatory data management

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 Compliance Manager (CRCM) - The International Association of Risk and Compliance Professionals (IARCP)The International Association of Risk and Compliance Professionals (IARCP)

Required Skills

Client Relations, Collaboration Tools, Data Analytics, Executive Presence, Generative AI, Lean Six Sigma (LSS), Microsoft Azure, Personal Effectiveness, Storytelling

Language

English (Required)

Language Proficiency -

Proficient - C2

Additional Job Location -

Job Type

Regular

Master Skill List -

Regulatory Affairs - Operations

Remote Type -

Hybrid

Work Shift -

Day Job (India)

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.