Genpact Hiring Technical Associate – Regulatory Affairs Jobs |
Genpact is inviting applications for the role of Technical Associate – Regulatory Affairs for the US market, offering an excellent opportunity for life science graduates with regulatory publishing expertise. This role focuses on eCTD submissions, global regulatory compliance, and advanced publishing systems, making it ideal for candidates aiming to build a strong career in pharmaceutical regulatory affairs within a technology-driven global organization. Interested candidates apply for the exciting opportunity at Genpact Careers.
Job Description: Technical Associate – Regulatory Affairs-LIF022785
Inviting applications for the role of Technical Associate for the US market
You should be fresher or have a minimum of years of experience, and have good knowledge of ICH guidelines and CTD Structure & Expertise with Publishing Tools like Liquent, DocuBridge, etc.
Responsibilities
- 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 the authority of submission receipt, capturing and 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.
We seek qualifications in you!
- 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 at an advanced level in the 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 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 an industry-standard electronic document management system.
Minimum Qualifications: Preferred Qualifications/ Skills
Genpact is an Equal Opportunity Employer and considers applicants for all positions without regard to race, color, religion or belief, sex, age, national origin, citizenship status, marital status, military/veteran status, genetic information, sexual orientation, gender identity, physical or mental disability or any other characteristic protected by applicable laws. Genpact is committed to creating a dynamic work environment that values respect and integrity, customer focus, and innovation.
- Job: Technical Associate
- Primary Location: India-Mumbai
- Schedule: Full-time
- Education Level Bachelor’s / Graduation / Equivalent
- Job Posting: Dec 11, 2025, 6:59:07 PM
- Unposting Date: Ongoing
- Master Skills List: Operations
