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If you thrive in a fast-moving, tech-driven setting, 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 Specialist-Regulatory Affairs -Labelling Operations

**Work Location**: Hyderabad

Shift- Flexible

Labeling Strategist

- Bachelors degree, in scientific discipline, or relevant/equivalent with 10 years of experience in Regulatory Affairs Labeling or equivalent in highly regulated environment
- Create, prepare, and revise CCDS, US and EU labeling for mature and life cycle products assigned to obtain company and/or agency approval.
- Coordination of labeling review and approval throughout the E2E labeling process, which includes preparation of labeling components for submission to regulatory agencies, participation in labeling negotiations with agencies resulting in product approvals or labeling updates,



and release of labeling for use throughout the company.
- Provides oversight for team and provide strategic guidance on complex labeling projects.
- Must be able to work with all levels of associates and direct management within the Company (domestic/international) and demonstrate good communication, interpersonal and organizational skills.
- Demonstrated knowledge and understanding of regulatory requirements for the CCDS, US and EU and local labeling implementation and the dynamics of Labeling Team purpose and objectives.
- Ability to read and interpret HA regulations and guidance, and underlying SOPs
- Proven ability to lead regulatory strategy into labeling strategy
- Strong ability to lead meeting and propose labeling strategy, working well in cross-functional teams, and able to negotiate, resolve conflict and build consensus.
- Lead a multidisciplinary labeling working group and provide labeling strategy proposal (Global Regulatory Affairs, Global Pharmacovigilance, Global Medical Affairs, Legal, Communication, preclinical and CMC)
- Proficient in presenting to senior management when required.
- Highly detail oriented, strong analytical and organized skills, project management skills, self-starter, leadership skills, critical thinking required, strong ability to network and coordinate discussions across all levels of the company to reach resolution on labeling topics.
- Must be able to construct a Company Response (MAH response)



for health authority questions related to labeling.

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.

📌 Specialist - Regulatory Affairs - Labelling (Hyderabad)
🏢 Genpact
📍 Hyderabad