Lead Consultant – Regulatory Affairs

Sr. Consultant - Regulatory Affairs 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 and on LinkedIn , YouTube , X , and Facebook . Job Description We are inviting applications for the role of lead Associate or lead Consultant Regulatory Affairs. Responsibilities: - Responsible for leading and executing CMC regulatory strategies for assigned post approval pharmaceutical products in alignment with global regulations guidance and defined regulatory strategies including preparation and critical review of data and documents required for post approval CMC submissions and lifecycle management. - Accountable for authoring reviewing and coordinating CMC documentation to support worldwide post approval changes and lifecycle activities (variations supplements amendments) for commercial products under the strategic direction of senior regulatory CMC scientists or product leads. - Experienced in evaluating scientific and technical information to assess the merits and regulatory impact of proposed post approval changes ensuring that rationales are clearly articulated risk based and fully supported by appropriate data. - Able to prioritize plan and drive multiple CMC post approval projects in parallel ensuring timely preparation review and submission of high quality dossiers in line with agreed project plans regulatory timelines and internal milestones. - Works effectively with cross functional teams (e.g. - QA QC manufacturing supply chain packaging device and analytics) to track and close out documentation gaps coordinate on change implementation status and provide clear concise regulatory updates to stakeholders through appropriate communication channels. - Demonstrates strong written and verbal communication skills including the ability to translate complex technical concepts into clear regulatory justifications and to influence decision making in cross functional and global forums. - Shows sound understanding of related technical disciplines (such as pharmaceutical manufacturing analytical testing quality assurance and quality systems) and applies this knowledge when defining regulatory strategies and compiling CMC dossiers. - Proven ability to identify regulatory risks and opportunities generate innovative yet compliant solutions to issues and collaborate effectively with internal and external partners to align on regulatory pathways. - Active participation in departmental and cross functional continuous improvement initiatives such as enhancement of templates processes systems; - maintenance of standard operating procedures and internal guidelines etc. - Demonstrates flexibility and resilience in managing changing priorities unforeseen regulatory queries or health authority expectations and time sensitive projects while maintaining accuracy and compliance. - Exhibits strong leadership stakeholder management and interpersonal skills including mentoring junior colleagues and representing CMC regulatory function in project and governance meetings. - Possesses advanced working knowledge of MS Office and relevant regulatory/quality IT systems (e.g. - document management RIMS and tracking tools) to efficiently prepare manage and archive CMC regulatory documentation. Qualifications Bachelors - Health Administration, Bachelors - Healthcare, Bachelors - Pharmacy, Masters - Public Health, Masters - Regulatory Affairs Certifications Certified Compliance Officer (CCO) - VskillsVskills, Regulatory Affairs Certification (RAC) - UdemyUdemy Required Skills Change Management, Data Consulting, Data Management, Project Management, Quality Assurance (QA), Regulatory Affair Management, Regulatory Information Management, Strategic Planning Language English Language Proficiency - Proficient - C2 Additional Job Location - Job Type Regular Master Skill List - Regulatory Affairs - Practice 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.