Regulatory Affairs Jobs at Genpact | Chemistry Graduates Apply Now
Are you looking for exciting regulatory affairs jobs where innovation, AI, and global impact come together? Genpact is inviting applications for the exciting role of Lead Associate – Regulatory Affairs, a position designed for professionals who excel in a highly regulated environment and thrive in fast-paced, technology-driven workplaces. If you’re ready to drive digital transformation and contribute to cutting-edge regulatory operations for the US market, this role offers the perfect platform to elevate your career.
About Genpact
Genpact is a global leader in advanced technology, AI-driven solutions, and digital transformation. With more than 140,000 professionals worldwide, Genpact combines deep industry expertise with cutting-edge innovation to help enterprises operate smarter, grow faster, and stay ahead. Built on a culture of curiosity, courage, and continuous improvement, Genpact empowers businesses to shape the future through data, technology, and AI.
Role: Lead Associate, Publisher for US Market – Regulatory Affairs (Operations)
Inviting applications for the role of Lead Associate, Publisher for the US market – Regulatory Affairs – Operations.
Responsibilities
The role demands an experienced Publisher with demonstrated ability to execute responsibility in a highly regulated and process-driven environment. The person will be responsible
for all activities related to:- Submission Publishing and performing final technical quality review and technical validation (eCTD) for Canada and US submissions.
- 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, capturing the electronic receipt and metadata in RIM, and communicating submission receipt to key stakeholders.
- Monitoring and reporting submission activity, reporting volume, timelines, and quality metrics; informing future planning and forecasting; supporting overall regulatory intelligence.
Qualifications We Seek in You!
Minimum Qualifications
- Bachelor’s degree, preferably in Pharmacy, Medicine, Chemistry, or related Life science discipline, with relevant pharmaceutical industry experience.
- Mandatory Knowledge of ICH, FDA, and EMA guidelines.
- Working knowledge of eCTD/CTD/NEES submission types and industry standard publishing systems.
- Advanced level in the English language.
- In-depth working knowledge of eCTD/CTD/NEES/Paper submission types and publishing systems.
- Expertise with Publisher applications.
- Effective communication, time management, and organizational skills.
- Technical troubleshooting abilities.
- 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 systems.
Preferred Qualifications & Key Attributes
- Enthusiasm & confidence.
- Adherence to principles and values.
- Strong 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 – Gain hands-on experience, mentorship, and continuous learning.
- Work with the best – Join 140,000+ bold thinkers and problem-solvers.
- Thrive in a values-driven culture – Courage, curiosity, integrity, and inclusion fuel your ideas and growth.
