Regulatory Publishing Specialist

About the role

Genpact is seeking a Regulatory Publishing Specialist to manage the end‑to‑end publishing process for electronic Common Technical Document (eCTD) submissions in the United States. The role operates in a highly regulated, process‑driven environment and supports global pharmaceutical affiliates in delivering compliant submissions to health authorities.

Key responsibilities

• Publish and perform technical validation of eCTD packages for US regulatory submissions.
• 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.
• Upload and manage correspondence from health authorities, including commitments and related documentation.

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.
• Effective time‑management, organizational and communication skills.
• Flexibility to adapt to a changing environment.

Required skills

• Working knowledge of eCTD, CTD and NEES submission types.
• Experience with industry‑standard publishing systems.
• Proficiency in English (advanced level).

What we offer

• Opportunity to work at the forefront of AI, automation and digital innovation.
• Exposure to global enterprises and complex regulatory challenges.
• Career acceleration within a leading technology services firm.