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Chemistry Jobs at Genpact | Lead Associate – Regulatory Affairs role
Chemistry Jobs at Genpact. Step into a future-ready career with Genpact as a Lead Associate in Regulatory Affairs, where technology, AI-driven transformation, and regulatory excellence converge. This role empowers you to manage global submissions, ensure compliance, and support critical operations in a fast-evolving pharmaceutical landscape, perfect for professionals who thrive in dynamic, innovation-led environments. Interested candidates apply now for the exciting opportunity at Genpact Careers.
Inviting applications for the role of Lead Associate – Regulatory Affairs Operations Global
This role directly contributes to the Company’s revenue growth and margin by leading operational teams in Regulatory Space. Specifically, the Lead Consultant is required to:
Responsibilities
- The Role demands for a 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.
- 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 affiliate can dispatch to authority.
- 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.
- Capturing submissions-related correspondence from health authorities, such as uploading documentation, commitments and metadata.
Qualifications
- 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 and FDA guideline for US market.
- Working knowledge of eCTD/ CTD/NEES types of submission, industry standard publishing systems.
- Should be advanced level in 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.
Preferred Qualifications/ Skills
- Experience and have good knowledge of ICH guidelines and CTD Structure & Expertise with Publishing Tools like Liquent, DocuBridge, etc.
Job Details
- Job Title: Lead Associate
- Primary Location: India-Mumbai
- Schedule: Full-time
- Education Level: Bachelor’s / Graduation / Equivalent
- Master Skills List: Operations
- Job Category: Full Time
