Lead Consultant Regulatory Affairs

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.
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Inviting applications for the role of Lead Consultant - Regulatory affairs.
This program is intended to support client in their requested requirement for regulatory submissions that may have impact on registrations of small molecules biologics and combination products.

Responsibilities
Maintain global regulatory oversight of assigned established products
Representation of Global Regulatory Affairs (GRA) in product-specific cross functional teams
Establish global regulatory strategies that ensure keeping the assigned established products on the market globally
Experience in directly detailing with EMA (communication negotiation) meetings for Centrally approved products (CAP)
Well versed with EU guidelines and procedures for CAP MRP / DCP super grouping work sharing
Provision of regulatory guidance and operational excellence for worldwide regulatory maintenance activities for assigned medicinal products including but not limited to Line Extensions Renewals Variations (Type 1A Type 1B Type 11) Periodic Safety Reports (e.g. PSUR) Risk Management Plans Direct Healthcare Professional Communication HA Requests HA Interactions (e.g. Scientific Advice) Referrals Production Transfers Marketing Authorization Transfers or Withdrawals Marketing Authorization Applications in the context of late geographical expansion Post-marketing Clinical Trial Activities etc.
Provision of global strategic regulatory guidance and input to key regulatory documents (e.g. CTD Modules 2 4 5 and selected Module 1 parts) according to international regulatory standards as well as Client processes.
Maintain up-to-date knowledge and oversight of global regulatory requirements guidelines evolving regulatory trends and developments as well as monitoring of relevant product-specific competitor information
Management of lifecycle submissions (Variations PSURs/PBRERs according to the products)
Prepare content plan and Finalise cover letter
Collection of document requirements according to the request and timelines
Dispatch package to Local country representatives or HA and archival of package in archival system
Request of registration samples
Coordination and preparation of supportive documents (general statements CPPs etc.) including legalisation of documents
Support and coordination of audit and inspection related activities
Acting and living in client processes and systems
Experience:
Relevant experience in life cycle management of products.
Qualifications we seek in you!
Minimum Qualifications
Atleast Bachelors degree required in for Pharmaceutical: science engineering or related field (advanced degree preferred).
Language: English
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
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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.
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