Jubilant Generics Limited is an integral part of Jubilant Pharmova, a global pharmaceutical giant renowned for its high-quality medicines. The company has a robust presence in key international markets, including the US, EU, and various emerging markets. With a steadfast commitment to innovation, compliance, and improving patient lives worldwide, Jubilant Generics has established itself as a trusted and rapidly growing name in the pharma industry. Working here means being part of a team that values excellence and offers a dynamic professional environment.
Job Description: Regulatory Affairs Executive (US Market)
This Regulatory Affairs role is specifically focused on managing submissions and compliance for the lucrative US market. The selected candidate will be at the forefront of the company’s regulatory strategy.
Key Responsibilities:
- Prepare, review, and submit high-quality ANDA filings and eCTD submissions to the USFDA.
- Manage complete lifecycle management of drug applications post-approval.
- Handle and respond to regulatory queries and information requests from the USFDA efficiently.
- Review and update product labeling to ensure strict compliance with the latest USFDA requirements.
- Manage post-approval submissions such as Annual Reports, CBE-30, and Prior Approval Supplements (PAS).
- Ensure all submissions adhere to USFDA guidelines and are completed within stipulated timelines.
- Coordinate effectively with cross-functional teams including Quality Assurance, Research & Development (R&D), and Manufacturing.
Eligibility Criteria & Qualifications
To apply for these Regulatory Affairs jobs at Jubilant Generics, candidates must meet the following criteria:
- Experience: A minimum of 3 to 7 years of relevant experience in Regulatory Affairs within the pharmaceutical industry.
- Mandatory Expertise: Proven and hands-on experience in US market submissions is essential. This must include working on ANDA, eCTD, and lifecycle management.
- Education: A bachelor’s or master’s degree in Pharmacy (B.Pharm / M.Pharm) or a postgraduate degree in Life Sciences.
- Skills: In-depth knowledge of USFDA guidelines, excellent communication skills, and strong analytical and problem-solving abilities.
Job Details
| Aspect | Details |
|---|---|
| Company | Jubilant Generics Limited |
| Job Role | Regulatory Affairs Executive |
| Experience Required | 3 – 7 Years |
| Key Market | United States (US) |
| Education | B.Pharm, M.Pharm, or Life Sciences Post-Grad |
| Job Location | Corporate Office, Greater Noida |
| Salary | Competitive, based on experience |
How to Apply for Jubilant Generics Recruitment
Interested and eligible candidates can apply for these pharma jobs in Noida by following these steps:
- Prepare your updated resume or CV.
- Email your CV to the following hiring managers:
- Important: Use the subject line: “Application – Regulatory Affairs US Market”. This ensures your application is processed quickly.