Specialist - Regulatory Affairs - Operations 4B

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

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

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

Pharmaceutical Regulatory Affairs

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.