Sr. Associate - Regulatory Affairs - Operations 5B

Sr. Associate \- Regulatory Affairs \- Operations**Ready to turn bold ideas into real\-world impact?**

At Genpact, we don’t just adapt to change, we lead it. AI and digital innovation are transforming the way businesses work, and we’re at the forefront of it. Genpact’s AI Gigafactory, our industry\-first accelerator, exemplifies how we scale advanced technology solutions to help global enterprises work smarter, grow faster, and transform at scale. Whether tackling complex challenges through large\-scale models or agentic AI, our breakthrough solutions tackle companies’ most complex challenges.

If you thrive in a fast\-moving, innovation\-driven environment, love building and deploying cutting\-edge AI solutions, and want to push the boundaries of what’s possible, this is your moment.

Genpact (NYSE: G) is an agentic and advanced technology solutions company. We leverage process intelligence and artificial intelligence to deliver measurable outcomes. With a strong partner ecosystem and decades of client trust, we provide innovative solutions that transform how businesses run. Powered by a team with an active learning mindset and client centricity at its core, we deliver lasting value for the world’s leading enterprises.

Get to know us at genpact.com and on LinkedIn, YouTube, X, and Facebook.

• *Job Description**

• *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 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.

• *Qualifications**

Bachelors \- Health Administration, Bachelors \- Healthcare, Bachelors \- Pharmacy, Masters \- Public Health, Masters \- Regulatory Affairs**Certifications**

Certified Compliance Officer (CCO) \- VskillsVskills, Certified Regulatory and Compliance Professional (CRCP) \- JSS UniversityJSS University, Certified Regulatory Compliance Manager (CRCM) \- The International Association of Risk and Compliance Professionals (IARCP)The International Association of Risk and Compliance Professionals (IARCP)**Required Skills**

Publishing, Regulatory Submissions**Language**

English (Required)**Language Proficiency \-**

Elementary \- A2**Additional Job Location \-**

• *Job Type**

Regular**Master Skill List \-**

Regulatory Affairs \- Operations**Remote Type \-**

Office**Work Shift \-**

Night Job (India)**Why join Genpact?**

• **Lead AI\-powered transformation** – Drive innovation and solve real\-world business challenges that matter
• **Make an impact** – Help global enterprises solve business challenges that matter
• **Accelerate your career** – Gain hands\-on experience, mentorship, and world\-class learning opportunities to stay ahead
• **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 140,000\+ coders, tech shapers, and growth makers at Genpact and take your career in the only direction that matters: Up.

Let’s build tomorrow together.

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.

Furthermore, please do note that Genpact does not charge fees to process job applications and applicants are not required to pay to participate in our hiring process in any other way. Examples of such scams include purchasing a 'starter kit,' paying to apply, or purchasing equipment or training.