BPharm Job at Genpact | Apply Now for Lead Regulatory Affairs Role
Looking for a Regulatory Affairs Job at Genpact Jobs Mumbai? This opportunity is ideal for candidates seeking a BPharm Job or a career in pharmaceutical science within pharma operations. Join a global leader and work on regulatory submissions, eCTD publishing, and compliance. Build your expertise in regulatory affairs operations while growing in a fast-paced, innovation-driven environment.
About Genpact
Genpact is a global professional services company delivering digital transformation and advanced technology solutions to leading enterprises. Known for innovation and operational excellence, Genpact offers exciting Genpact Jobs across industries, including life sciences and pharma. The company provides excellent opportunities for candidates seeking a Regulatory Affairs Job or a BPharm Job in a global environment. With strong expertise in AI, data, and analytics, Genpact empowers professionals to work on high-impact projects. Its inclusive culture, continuous learning programs, and career growth opportunities make it a top destination for aspiring professionals worldwide.
- Job: Lead Associate – Regulatory Affairs (LIF023816)
- Location: India-Mumbai
Job Overview
The Regulatory Affairs Job at Genpact Mumbai is for the role of Lead Associate – Regulatory Affairs Operations (Junior Publisher for US market). This position involves handling eCTD submissions, regulatory publishing, and compliance processes. It is a great opportunity under Genpact Jobs for candidates looking for a BPharm Job or a life science role in the pharmaceutical and regulatory domain.
Responsibilities
- The Role demands a publisher with demonstrated ability to execute responsibility in a highly regulated & process-driven environment.
- Publishing and performing technical validation of eCTD for US submissions.
- Performing final technical quality review.
- Dispatching submission to the relevant authority (eCTD/CTD/NeeS/Paper) or affiliate so that the affiliate can dispatch to the authority.
- Performing post-submission processing activities such as receiving acknowledgment from the authority of submission receipt, capturing and the electronic receipt and metadata in RIM, and communicating submission receipt to key stakeholders.
- Capturing submissions-related correspondence from health authorities, such as uploading documentation, commitments, and metadata.
Qualifications
- Bachelor’s degree, preferably in Pharmacy, Medicine, Chemistry, or a related Life science discipline, required with relevant experience in the pharmaceutical industry.
- Mandatory Knowledge of ICH and FDA guidelines for the US market.
- 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.
- Effective time management and organizational skills.
- Effective communication.
- Flexibility to adapt to a changing environment.
Skills Required
- Knowledge of ICH and FDA guidelines
- Experience with eCTD/CTD/NEES submissions
- Familiarity with publishing tools like Liquent, DocuBridge
- Strong communication and time management skills
- Attention to detail and regulatory compliance knowledge
- Interest in Regulatory Affairs Job and pharma operations
This is a great opportunity under Genpact Jobs for candidates aiming to build a career in regulatory affairs and pharma operations. Whether you are targeting a BPharm Job or a specialized Regulatory Affairs Job, this role offers strong learning exposure, global experience, and career growth. Join Genpact and take your professional journey to the next level.
