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If you thrive in a rapid-moving, tech-driven environment, 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 Specialit - Regulatory Affairs -Operations

**Work Location**: Mumbai

Responsibilities

Support through a number of regulatory functions specific to post-approval, lifecycle management capacities which includes

- Provide scientific inputs and actively involved in RA CMC strategic discussions
- Monitor assumptions, risks and dependencies
- Manage and oversee regulatory post approval Chemistry, Manufacturing and Controls (CMC) changes involving deliverables such as:
- Provide of regulatory evaluation of change control (affected countries, data/documentation requirements per country, change category per country and regulatory procedure per country) and regulatory strategy




- Provide tracking list and review documentation
- Dispatch final documentation package to Local Regulatory Affairs (LRA) in affected countries
- Monitor timely submission and approval in affected countries
- Manage and coordinate responses to health authority questions
- Overall planning of all CMC regulatory changes per product together with relevant interfaces
- Represent G CMC RA in cross-functional teams
- Manage and oversee support for renewals and post approval CMC commitment involving deliverables such as:
- Provide regulatory requirements and regulatory strategy to relevant interfaces
- Review documentation
- Dispatch final documentation package to Regional Regulatory Lead (RRL) for further distribution to LRAs
- Manage and coordinate responses to health authority questions
- Overall planning of all renewals per product together with relevant interfaces
- Represent G CMC RA in cross-functional teams

Qualifications we seek in you!

Minimum Qualifications

- Bachelor's Degree or higher in life sciences field.

Preferred Qualifications/ Skills

- Bachelor's or Master's degree required in Pharmacy, Science, or related field (advanced degree preferred) with global Regulatory CMC experience
- Research and stay updated on regulations relevant to the industry. Develop and implement compliance policies and procedures.
- Conduct internal audits and risk assessments.



Provide guidance and training to staff on compliance matters.
- Monitor and report on compliance issues to management.
- Collaborate with legal and other departments to address compliance concerns.
- Respond to compliance inquiries from regulatory authorities.

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 - Operations (Nashik)
🏢 Genpact
📍 Nashik