BPharm/MPharm Assistant Manager Job – at Jubilant Generics, Apply Now!
Are you a skilled regulatory affairs professional looking to lead ANDA submissions and manage the product lifecycle for the US market? Jubilant Generics Limited, part of the globally renowned Jubilant Bhartia Group, is hiring for the position of Assistant Manager – Drug Regulatory Affairs (US Market) in Noida. Apply now to accelerate your career in a dynamic, innovation-driven pharmaceutical environment.
- Job Opening: Assistant Manager – Drug Regulatory Affairs (US Market)
- Location: Greater Noida, Uttar Pradesh, India
- Department: Drug Regulatory Affairs – Formulations
About the Company
Jubilant Generics Limited is a part of the Jubilant Bhartia Group, a global conglomerate founded by Mr. Shyam S Bhartia and Mr. Hari S Bhartia. The group has a strong presence in diverse sectors including Pharmaceuticals, Contract Research and Development Services, Proprietary Novel Drugs, and more. With four flagship companies under its umbrella, Jubilant Bhartia Group aims to make a significant impact in various industries. Currently employing around 43,000 individuals worldwide, the group continues to drive innovation and excellence in its operations.
BPharm/MPharm Assistant Manager Job – Position Summary
The Assistant Manager will be responsible for:
- Preparation, review, and submission of ANDAs for the US FDA.
- Lifecycle management (LCM) of approved products.
- CMC assessments, eCTD publishing, labeling, and regulatory intelligence updates.
BPharm/MPharm Assistant Manager Job – Key Responsibilities
- Authoring and reviewing drug product dossiers (ANDAs) for the US market.
- Evaluation of post-approval changes: Annual Reports, CBE-30, PAS filings.
- Publishing using eCTD software and preparing SPL files.
- Review of CMC Module 3 and Module 1 for completeness and compliance.
- Coordination with QA, R&D, ADL, and API vendors for regulatory documents and resolutions.
- Labeling and artwork review in accordance with FDA guidelines.
- Handling DMFs, agency queries, and supporting regulatory inspections.
- Staying updated with FDA regulations and regulatory intelligence.
BPharm/MPharm Assistant Manager Job – Eligibility Criteria
- Qualification: B.Pharm / M.Pharm
- Experience: 3–5 years in Regulatory Affairs (US generics market experience preferred)
- Strong knowledge in CMC, post-approval changes, and ANDA lifecycle maintenance
- Excellent written and verbal communication skills
- Experience with eCTD publishing tools is essential
Why Join Jubilant?
- Work in one of India’s leading pharma conglomerates
- Exposure to global regulatory pathways and high-impact filing strategies
- Join a team focused on innovation, compliance, and accelerated product launches
- Inclusive and supportive work culture with continuous growth opportunities
Keywords: Regulatory Affairs jobs in Noida, ANDA filing jobs India, Drug Regulatory Affairs US market, Pharma regulatory job openings 2025, Jubilant Pharmova careers, Regulatory Affairs specialist Noida, CMC regulatory jobs
