Lead Consultant -Regulatory Affairs
- Genpact
- 4 - 9 years
- Mumbai
- 2 days ago
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Job Description
Ready to shape the future of work?
At Genpact, we dont just adapt to changewe drive it. AI and digital innovation are redefining industries, and were leading the charge. Genpacts AI Gigafactory, our industry-first accelerator, is an example of how were scaling advanced technology solutions to help global enterprises work smarter, grow faster, and transform at scale. From large-scale models to agentic AI, our breakthrough solutions tackle companies most complex challenges.
If you thrive in a fast-moving, tech-driven environment, love solving real-world problems, and want to be part of a team thats shaping the future, this is your moment.
Genpact (NYSE: G) is an advanced technology services and solutions company that delivers lasting value for leading enterprises globally. Through our deep business knowledge, operational excellence, and cutting-edge solutions we help companies across industries get ahead and stay ahead. Powered by curiosity, courage, and innovation, our teams implement data, technology, and AI to create tomorrow, today. Get to know us at genpact.com and on LinkedIn, X, YouTube, and Facebook.
Inviting applications for the role of Lead Consultant, CMC Regulatory Affairs
Work location- Mumbai (work from office)
This role directly contributes to the Companys revenue growth and margin by leading operational teams in Regulatory Space. Specifically, the Lead Consultant is required to:
Responsibilities
- Strategize and provide CMC support for innovation projects/site transfer/due diligence assessment.
- Strategy preparation for the EU variation submissions Work sharing, Super grouping, Annual reports.
- Coordinate and support dossier preparation, review in line with regulatory requirements to finalize the submission.
- Assessment of Deficiency letters from HA and coordinate with stake holders for HAQ responses for timely submission.
- Act as the primary point of contact between global Regulatory CMC and local affiliates for submission package preparation and delivery.
- Translate global CMC strategies into actionable regional plans, ensuring alignment with country-specific requirements.
- Plan the due dates and coordinate the on-time delivery of the document, to meet regulatory submission timelines.
- Creation & maintenance of Veeva activities such as ROs, Submissions, Registrations etc. in Veeva Vault before/after Submission/ Approval.
- Active Participation in the project meetings and provide input as necessary.
- Maintaining the related trackers and updating the information accordingly.
- Review of local documents, Cover Letter, electronic application form, LOA, LOI.
Qualifications we seek in you!
Minimum Qualifications
- Long experience in CMC Regulatory handling for EU/US regions.
- Understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market support.
- Strong practical experience with global HA requirements, beyond EU/US.
- Proven ability to understand and communicate regulatory strategy to drug development, registration, and post-market support teams.
- Able to deal with issues of critical importance with minimal oversight. Exercises good judgment in elevating and communicating actual or potential issues to line management.
- Understands who is responsible for different decisions and escalates as necessary.
- Applies directions taken by the company.
- Demonstrates emerging leadership, problem-solving ability, flexibility and values teamwork.
- Intentionally promotes an inclusive culture.
- Applies given prioritization framework with limited support.
- Excellent written and oral communication skills required.
- Excellent skills in leadership, collaboration, negotiation, problem solving, and fostering interpersonal connections through teamwork.
Preferred Qualifications/ Skills
- Pharmaceutics and Chemistry background is preferred.
Why join Genpact?
Be a transformation leader Work at the cutting edge of AI, automation, and digital innovation
Make an impact Drive change for global enterprises and solve business challenges that matter
Accelerate your career Get hands-on experience, mentorship, and continuous learning opportunities
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 tech shapers and growth makers at Genpact and take your career in the only direction that matters: Up.
Lets 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.
Job Classification
Industry: BPM / BPOFunctional Area / Department: Legal & RegulatoryRole Category: Legal & Regulatory - OtherRole: Legal & Regulatory - OtherEmployement Type: Full timeContact Details:
Company: GenpactLocation(s): Mumbai
Keyskills: Regulatory Affairs Drug Regulatory Affairs CTD Submission DocuBridge Pharmaceutical Ectd Document Review ICH Liquent
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