Regulatory Affairs Analyst

About the role

Genpact is seeking a Regulatory Affairs Analyst to manage and validate electronic submissions for US pharmaceutical products. The role involves ensuring compliance with ICH and FDA guidelines while supporting the end‑to‑end submission process.

Key responsibilities

• Publish and perform technical validation of eCTD submissions for the US market.
• Conduct final technical quality reviews before dispatch.
• Dispatch submissions (eCTD/CTD/NEES/Paper) to the appropriate authority or affiliate.
• Handle post‑submission activities, including receipt acknowledgements, metadata capture in RIM, and stakeholder communication.
• Capture and upload correspondence from health authorities, including documentation, commitments, and metadata.

Required profile

• Bachelor’s degree in Pharmacy, Medicine, Chemistry, or a related life‑science discipline.
• Relevant experience in the pharmaceutical industry.
• Strong knowledge of ICH and FDA guidelines for the US market.
• Advanced proficiency in English.
• Effective time‑management, organizational, and communication skills.
• Ability to adapt to a changing regulatory environment.

Required skills

• eCTD submission systems
• CTD submission systems
• NEES submission systems
• ICH guideline expertise
• FDA guideline expertise
• Industry‑standard publishing platforms
• Regulatory Information Management (RIM) tools

What we offer

• Opportunity to work at the forefront of AI, automation, and digital innovation.
• Impactful projects that drive change for global enterprises.
• Career acceleration through hands‑on experience and mentorship.