Regulatory Affairs Jobs at Genpact | Life Sciences | Apply Now
Genpact, a leader in advanced technology services, is inviting applications for the Lead Associate, Publisher role within Regulatory Affairs Operations, focused on the US and Canadian markets. This critical regulatory affairs jobs opportunity requires expertise in ICH guidelines, CTD structure, and proficiency with publishing tools like Liquent or DocuBridge. If an applicant holds a Bachelor’s degree in Pharmacy or a related Life sciences jobs discipline and is ready to execute responsibilities in a highly regulated, tech-driven environment, they should explore this immediate Genpact careers role.
- Designation: Lead Associate – Regulatory Affairs
- Location: India – Mumbai
- Job ID: LIF022203
About The Company
Genpact is an advanced technology services and solutions company that is actively driving change through AI and digital innovation. Joining Genpact means becoming part of a values-driven culture of 140,000+ problem-solvers who implement data, technology, and AI to help global enterprises work smarter.
Key responsibilties
This role requires an experienced Publisher responsible for ensuring the technical quality and regulatory compliance of submissions to international health authorities.
- Submission Publishing: Lead Submission Publishing and perform final technical quality review and technical validation (eCTD) for Canada and US submissions.
- Submission Types: Must know about MAA, NDS, ANDS, IND, DMF, NDA, ANDA and BLA submissions (e.g., Safety Submissions, Annual reports, Protocol and amendment, original application).
- Dispatch & Post-Submission: Dispatch submissions to CESP, EMA, HC, and US FDA. Perform post-submission processing activities, including receiving acknowledgements and capturing metadata in RIM (Regulatory Information Management).
- Metrics & Monitoring: Monitoring and reporting submissions activity, including volume, timelines, and quality metrics.
Essential Qualifications and Expertise
Minimum Qualifications
- Education: Bachelor’s degree, preferably in a Life science discipline, required with relevant experience in the pharmaceutical industry.
- Regulatory Knowledge: Mandatory knowledge of ICH, FDA, and EMA guidelines.
- Technical Expertise: In-depth working knowledge of eCTD/ CTD/NEES types of submission, industry standard publishing systems, and desktop applications. Expertise with Publisher applications and industry-standard electronic document management systems.
Key Skills
- Effective communication, time management, and organizational skills.
- Demonstrated project management and leadership skills.
- Strong attention to detail and ability to multitask.
If an applicant is a detail-oriented professional with mandated experience in eCTD publishing and global regulatory guidelines, such high-growth regulatory affairs jobs are ideal. They should apply now to accelerate their Genpact careers journey in Mumbai, leveraging their Life sciences jobs background to lead compliance operations.
