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 .

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