Regulatory Affairs Jobs at Genpact | Chemistry Grads Apply Now
Are you looking for Regulatory Affairs Jobs in a fast-growing global organization? Explore exciting Genpact Jobs and take the next step in your professional journey with a leading digital transformation company. This opportunity for Lead Associate – Regulatory Affairs at Genpact Careers is ideal for professionals with expertise in eCTD publishing, ICH guidelines, and US market submissions who want to thrive in a tech-driven, innovation-focused environment.
About Genpact Careers
Genpact is a global professional services firm delivering digital transformation by integrating advanced analytics, AI, automation, and deep industry expertise. Headquartered in New York and operating across multiple countries, Genpact supports leading enterprises in optimizing operations and driving innovation. With a strong commitment to integrity, inclusion, and continuous learning, Genpact Careers offers exceptional growth opportunities in technology, operations, and Regulatory Affairs Jobs worldwide.
Inviting applications for the role of Lead Associate, Publisher for the US market Regulatory Affairs
You should have experience and have good knowledge of ICH guidelines and CTD Structure & Expertise with Publishing Tools like Liquent, DocuBridge, etc.
Responsibilities
- The Role demands 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 the affiliate can dispatch to the authority.
- Performing post-submission processing activities such as receiving acknowledgement 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.
Requirements
- 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 be at 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.
Key Attributes
- Enthusiasm & confidence
- Adhere to our principles and values.
- Time Management skills.
Qualifications we seek in you!
Minimum Qualifications
- Bachelor’s degree, preferably in Pharmacy, Medicine, Chemistry, or a related Life science discipline, required with relevant experience in the pharmaceutical industry.
Job: Lead Associate
- Primary Location: India-Mumbai
- Schedule: Full-time
- Education Level: Bachelor’s / Graduation / Equivalent
- Unposting Date: Ongoing
- Master Skills List: Operations
- Job Category: Full Time
