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If you thrive in a fast-moving, tech-driven workplace, love solving real-world problems, and want to be part of a team thats shaping the future, this is your moment.
Genpact (NYSE: G) is an advanced technology services and solutions company that delivers lasting value for leading enterprises globally. Through our deep business knowledge, operational excellence, and cutting-edge solutions we help companies across industries get ahead and stay ahead. Powered by curiosity, courage, and innovation, our teams implement data, technology, and AI to create tomorrow, today. Get to know us at genpact.com and on LinkedIn, X, YouTube, and Facebook.

Inviting applications for the role of Regulatory Affairs Operations

**Work Location**: Hyderabad/Mumbai/Delhi NCR(Gurgaon, Noida)

Shift- Flexible

Have good knowledge of ICH guidelines and CTD Structure & Expertise with Publishing Tools like Liquent, DocuBridge, etc.

Duties:

• Lead software implementation projects at top pharma companies.

• Lead the solution design for how your customer will implement and use the Vault Regulatory suite (Vault Registrations, Vault Submissions, Vault Submissions Archive, Vault Publishing)

• Lead requirements workshops, design, prototype, configure and document content management/registration data solutions

• Architect multi-year and multi-phased implementation programs to deploy Vault RIM across an organization globally

• Program and project management including resource planning,



leading and motivating a cross-functional team, and project tracking and forecasting

• Primary customer liaison managing communication between the project team, customer and internal stakeholders

• Work closely with business and IT staff from the client to understand their requirements. Think critically to help them design the solution they actually need; not just the solution they think they need

• Ensure customer success from beginning to end of the engagement lifecycle

• Proven technical abilities and experience in designing and implementing IDMP solutions years experience working with life sciences companies performing system implementation experience either as a consultant, business or IT representative for: Document Management (Documentum, OpenText, Sharepoint), Registration Data Tracking Systems, XEVMPD, IDMP, SPL, eCTD

Hands on xEVMPD system implementation.

• In-depth knowledge of drug development processes and regulatory information management or regulatory submissions; including, Labeling, Submission Publishing and/or Viewing systems
• Proven ability to collaborate and communicate excellently with diverse stakeholders and ensure delivery to a high degree of satisfaction
• Influential; experience leading teams through hard decisions and negotiating compromises
• Expert on life sciences compliance and computer systems validation requirements
Ability to lead and implement IDMP strategy. Ability to lead a team of direct or matrixed colleagues to deliver on business commitments and project timelines.




Bachelor's degree required in science, engineering or related field (advanced degree preferred).
years relevant industry experience leading IDMP solutions for top pharma companies.

Education :

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

Why join Genpact?

• Be a transformation leader Work at the cutting edge of AI, automation, and digital innovation
• Make an impact Drive change for global enterprises and solve business challenges that matter
• Accelerate your career Get hands-on experience, mentorship, and continuous learning opportunities
• 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 tech shapers and growth makers at Genpact and take your career in the only direction that matters: Up.
• Lets 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.

📌 Senior Specialist - Regulatory Affairs - Operations (Maharashtra)
🏢 Genpact
📍 Maharashtra