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Jubilant Generics hiring Regulatory Affairs professionals
Jubilant Generics Limited
Regulatory Affairs Executive | 3–7 Yrs | Jubilant Generics Noida
Jubilant Generics hiring Regulatory Affairs professionals with 3–7 yrs experience for US market submissions in Greater Noida. Apply today!
Jubilant Generics Limited, a leading name in the pharmaceutical sector, is inviting applications for Regulatory Affairs (US Market) positions at its Corporate Office in Greater Noida. This is an excellent opportunity for experienced pharma professionals who want to contribute to regulatory submissions and compliance for one of the fastest-growing global pharma companies.
Company Overview
Jubilant Generics Limited is part of Jubilant Pharmova, a globally recognized pharmaceutical organization engaged in manufacturing and marketing high-quality medicines. With strong regulatory approvals and a presence in the US, EU, and emerging markets, Jubilant Generics is committed to improving patient health through innovation, compliance, and excellence.
Job Role & Responsibilities
As part of the Regulatory Affairs – US Market team, the selected candidate will be responsible for:
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Preparing and submitting ANDA filings, eCTD submissions, query responses, and lifecycle management activities for the US market.
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Reviewing and updating product labeling in compliance with USFDA requirements.
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Assessing and managing post-approval submissions including Annual Reports, CBE-30, and PAS.
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Ensuring adherence to USFDA regulatory guidelines and submission timelines.
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Coordinating with cross-functional teams including Quality, R&D, and Manufacturing.
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Handling regulatory queries and ensuring timely compliance.
Eligibility / Qualifications
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Experience: 3–7 years in Regulatory Affairs (pharma industry).
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Mandatory Requirement: Proven expertise in US market submissions including ANDA, eCTD, and lifecycle management.
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Qualification: B.Pharm / M.Pharm or Life Sciences graduate/postgraduate.
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Strong knowledge of USFDA guidelines and regulatory documentation.
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Excellent communication and problem-solving skills.
Location & Salary
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Work Location: Jubilant Generics Corporate Office, Greater Noida.
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Salary: Competitive, based on qualification and experience.
Application Process
Interested candidates can share their updated profiles at:
Mention “Application – Regulatory Affairs US Market” in the subject line for faster processing.
FAQs
Q1. Who can apply for this Regulatory Affairs opening?
Candidates with 3–7 years of RA experience and mandatory exposure to the US market (ANDA, eCTD submissions, lifecycle management).
Q2. What qualifications are preferred?
B.Pharm, M.Pharm, or postgraduates in Life Sciences with regulatory expertise.
Q3. What are the main responsibilities?
Regulatory submissions, labeling, lifecycle management, and compliance with USFDA guidelines.
Q4. Where is the work location?
Greater Noida – Corporate Office of Jubilant Generics.
Q5. How can I apply?
Send your CV to v-prateek.pandey@jubl.com and robin.shahi@jubl.com.
Summary Table
| Company | Jubilant Generics Limited |
|---|---|
| Vacancies | Regulatory Affairs (US Market) |
| Required Education | B.Pharm / M.Pharm / Life Sciences |
| Experience | 3–7 years in US Regulatory Affairs |
| Location | Greater Noida, Corporate Office |
To apply for this job email your details to robin.shahi@jubl.com