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Sr. 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

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) and responses to health authority questions for commercial products per established business processes and systems.
• Provide regulatory leadership as needed to product in-license/due diligence review, product divestment and product withdrawal.
• Collaborate effectively with cross‑functional teams (e.g., QA, QC, manufacturing, supply chain, packaging, device, and analytics), CMOs, and external partners to track and close out documentation gaps, compliant execution of change management, and conduct all activities with an unwavering focus on regulatory conformance.
• Ensure timely approvals for the submissions and Product supply continuity.
• Deliver all regulatory milestones for assigned products across the product lifecycle.
• Strong experience in CMC requirements for small molecule/biologic products.
• Proven experience in critically reviewing detailed scientific information to assess technical merits and suitability of scientific rationale to ensure information is presented clearly and conclusions are adequately supported by data.
• 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, Veeva Vault, RIMS, and tracking tools etc.) to efficiently prepare, manage, and archive CMC regulatory documentation.
• Demonstrates effective leadership, communication, interpersonal and negotiating skills.
• Ability to lead a team of direct or matrixed colleagues to deliver on business commitments and project timelines.

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 Compliance Manager (CRCM) - The International Association of Risk and Compliance Professionals (IARCP)The International Association of Risk and Compliance Professionals (IARCP)

Required Skills

Client Relations, Collaboration Tools, Data Analytics, Executive Presence, Generative AI, Lean Six Sigma (LSS), Microsoft Azure, People Leadership, Personal Effectiveness, Storytelling

Language

English (Required)

Language Proficiency -

Proficient - C2

Additional Job Location -

Job Type

Regular

Master Skill List -

Regulatory Affairs - Operations

Remote Type -

Office

Work Shift -

Flex Time (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.