Genpact Hiring Technical Associate – Regulatory Affairs | Apply Now
Explore exciting opportunities through Genpact Careers with the role of Technical Associate – Regulatory Affairs, one of the most sought-after Regulatory Affairs Jobs for freshers and early-career professionals. This position is perfect for candidates with knowledge of ICH guidelines, CTD structures, and regulatory publishing tools, offering a strong start in a tech-driven and innovation-led global organization.
Job Details:
- Job Title: Technical Associate
- Primary Location: India-Mumbai
About the Company:
Genpact (NYSE: G) is an advanced technology services and solutions company enabling global enterprises to stay ahead in a rapidly evolving digital landscape. With AI Gigafactory innovations and deep domain expertise, Genpact Careers offer professionals the opportunity to work on meaningful challenges powered by data, technology, and AI. Learn more on genpact.com and social platforms.
Job Description:
In this role, You should be fresher or have minimum years of experience and have good knowledge of ICH guidelines and CTD Structure & Expertise with Publishing Tools like Liquent, DocuBridge, etc.
Key Responsibilities In Genpact Careers:
- 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 Required For Genpact Careers:
- 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 advance 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
Key Attributes
- Enthusiasm & confidence
- Adhere to our principles and values.
- Time Management skills.
