Regulatory Affairs Job at Genpact | Apply for the Technical Associate Role
Genpact is inviting applications for a Technical Associate – Regulatory Affairs in Mumbai, India. This Regulatory Affairs Job is designed for freshers or candidates with minimum experience who possess strong knowledge of ICH guidelines, CTD structure, and expertise with publishing tools such as Liquent and DocuBridge. The Technical Associate will be responsible for submission publishing, technical validation for US and Canada markets, and dispatching applications to authorities like the FDA and Health Canada. A Bachelor’s degree in Pharmacy, Medicine, or Life Sciences is required to support complex regulatory filings, including IND, NDA, and ANDA submissions is required for the Genpact Job.
- Job Post: Technical Associate – Regulatory Affairs
- Location: Mumbai, India
- Job ID: LIF022785
About The Company
Genpact (NYSE: G) is a global advanced technology services and solutions company that implements data, technology, and AI to deliver lasting value for leading enterprises. With a workforce of over 140,000 employees, the company operates at the cutting edge of digital innovation, featuring an industry-first AI Gigafactory to scale advanced solutions. Genpact serves global clients across various industries, emphasizing operational excellence, deep business knowledge, and a values-driven culture built on curiosity, courage, and integrity.
Responsibilities of the Regulatory Affairs Job
- The Genpact Job demands an experienced Publisher with a 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 acknowledgment from the authority of submission receipt, capturing and recording the electronic receipt and metadata in RIM, and 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.
Qualifications required for Regulatory Affairs Job
- Bachelor’s degree, preferably in Pharmacy, 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 have an advanced level in the English language.
- In-depth working knowledge of eCTD/CTD/NEES/Paper types of submission, industry-standard publishing systems, and desktop applications.
- Expertise with Publisher applications.
- Effective communication, time management, and organizational skills.
- Technical Troubleshooting.
- 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 multitask.
- Expertise with industry-standard electronic document management system.
