Specialist - Regulatory Affairs - Operations 4A

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

• Responsible for implementing CMC regulatory strategies for assigned pharmaceutical products in accordance with global regulations, guidance and defined regulatory strategies along with the preparation and review of information required for development of regulatory CMC dossiers for commercial products of small molecules/ pharma, large molecules/ biologicals, etc.

• Work on authoring CMC documentation for worldwide marketing of pharmaceutical products for initial registration and life-cycle management submissions under direction of team scientists.

• Experience in reviewing scientific information to assess technical merits and suitability of scientific rationale to ensure information is presented clearly and conclusions are adequately supported by data.

• Able to prioritize & execute the project according to the project plan/timelines/schedules.

• Work with cross-functional teams to track and follow up outstanding documentation, coordinate on project status & reporting to stakeholders using different communication channels.

• Understanding of job responsibilities & processes of cross-functional teams, manufacturing sites, Quality Assurance, Quality control, etc. Prior experience in these departments is preferable.

• Experience in RA/ QA/ QC system and tools like SAP, documentum, Veeva, LIMS, spotfire, Power BI, etc is preferrable.

• Demonstrated oral and written communication skills and the ability to communicate issues in a succinct and logical manner. Strong listening skills.

• Demonstrated understanding of related fields (e.g., pharmaceutical manufacturing, analytical testing, and quality assurance).

• Ability to generate innovative solutions to problems and effectively collaborate with and communicate to key stakeholders.

• Active participation in departmental improvement activities such as system modifications, maintenance of standard operating procedures, internal guidelines, etc.

• Demonstrated flexibility in responding to changing priorities, multi-tasking and dealing with unexpected events.

• Effective leadership, communication, and interpersonal skills.

• Advanced knowledge of MS Office.

• Superior attentiveness to detail.

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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.