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Inviting applications for the role of Regulatory Affairs Analyst
The Role demands for a publisher with demonstrated ability to execute responsibility in a highly regulated & process driven environment, the Person will be responsible for all the activities related to.
Responsibilities
Publishing and performing technical validation of e CTD for US submissions. Performing final technical quality review. Dispatching submission to the relevant authority (e CTD/CTD/Nee S/Paper) or affiliate so that affiliate can dispatch to authority.



Performing post-submission processing activities such as receiving acknowledgement from authority of submission receipt; capturing and the electronic receipt and metadata in RIM; communicating submission receipt to key stakeholders. Capturing submissions-related correspondence from health authorities, such as uploading documentation, commitments and metadata.
Qualifications Minimum Qualifications
Bachelor’s degree, preferably in Pharmacy, Medicine, Chemistry, or related Life science discipline required with relevant experience in the pharmaceutical industry. Mandatory Knowledge of ICH and FDA guideline for US market. Working knowledge of e CTD/ CTD/NEES types of submission, industry standard publishing systems. Should be advance level in English language. In depth working knowledge of e CTD/CTD/NEES/Paper types of submission, industry standard publishing systems. Effective time management and organizational skills. Effective communication. Flexibility to adapt to a changing environment.
Preferred Qualifications
Enthusiasm & confidence Adhere to our principles and values. Time Management skills.
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. Let’s build tomorrow together.

📌 Regulatory affairs professional with experience in global ectd/ctd/nees/actd submissions (Ciudad de México)
🏢 Genpact
📍 Ciudad de México