Apply Online for Regulatory Affairs Technical Associate at Genpact

Genpact is a global professional services and solutions firm delivering outcomes that shape the future. Our 125,000+ people across 30+ countries are driven by our innate curiosity, entrepreneurial agility, and desire to create lasting value for clients. Powered by our purpose – the relentless pursuit of a world that works better for people – we serve and transform leading enterprises, including the Fortune Global 500, with our deep business and industry knowledge, digital operations services, and expertise in data, technology, and AI.

Post : Technical Associate - Regulatory Affairs

Job Description
• The Role demands for an experienced 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.
• Submission Publishing and performing final technical quality review and technical validation (eCTD) for Canada and US submissions.
• Should have knowledge about MAA, NDS, ANDS, IND, DMF, NDA, ANDA and BLA submissions e.g. Safety Submissions, Annual reports, OPDP submissions, Protocol and amendment, original application.
• Notifying relevant stakeholders that the Submission is ready for approval
• Dispatching submission to CESP, EMA, HC and US FDA.
• 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.
• Monitoring and reporting submissions activity, such as reporting volume, timelines, and quality metrics; informing future planning and forecasting activities; supporting overall regulatory intelligence.

Candidate Profile
• 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, FDA and EMA guidelines.
• Working knowledge of eCTD/ CTD/NEES types of submission, industry standard publishing systems.
• Should be advance level in English language.
• In depth working knowledge of eCTD/CTD/NEES/Paper types of submission, industry standard publishing systems.
• In depth working knowledge of industry standard publishing systems and desktop applications.
• Expertise with Publisher applications
• Effective communication, time management and organizational skills.
• Technical Trouble shooting
• Flexibility to adapt to a changing environment,
• Demonstrated project management and leadership skills.
• Skilled at fostering customer relationships and driving collaboration.
• Understanding of global regulatory processes and requirements.
• Strong attention to detail, ability to multi-task.

Key Attributes
• Enthusiasm & confidence
• Adhere to our principles and values.
• Time Management skills.

Additional Information
Qualification : Bachelor’s degree in Pharmacy, Medicine, Chemistry, or related Life science
Location : India-Mumbai
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Regulatory Affairs
End Date : 10th January 2026