Regulatory Affairs Trainee
3 days ago
Job Purpose:
To assist the Regulatory Affairs team in day-to-day activities related to CDSCO, ONDL and State FDA submissions, documentation, and compliance.
Key Responsibilities:
Submissions & Coordination
Preparation and submission of applications to CDSCO, ONDL and State FDA for:
Export NOC Application of Banned & Unapproved products
- Product Permission Application
- Free Sale Certificate Application
- Form-29 Application
- COPP Application
- Uploading old licensing data on ONDL portal
- CT-11 Application
Documentation & Record Keeping
- Maintain updated files for approvals
- Ensure proper archiving of all approvals
System & Portal Management
- Learn and support in operations on Sugam / ONDL / NSWS / XLN/ WHO-GMP/GRAS and other online submission systems.
Skills & Attributes:
- Basic understanding of CDSCO, FDA
- Good communication and coordination skills.
- Attention to detail, documentation accuracy, and willingness to learn.
- Proficient in MS Office (Word, Excel, PDF handling).
Qualifications
Essential: B.SC / B. Pharm with 1-2-year experience
Languages Known: English is Mandatory
-
Regulatory Affairs Specialist
2 weeks ago
Navi Mumbai, Maharashtra, India CELOGEN PHARMA PVT LTD Full time ₹ 2,00,000 - ₹ 4,00,000 per yearCompany OverviewCelogen Pharma Pvt. Ltd. is a leading pharmaceutical formulations exporter & manufacturer based in India. The company provides it products and services in multiple countries globally including West Africa, East Africa, South Asia, South East Asia, the Middle East, South America & Europe. Apart from promoting our branded products in the retail...
-
Officer - Regulatory Affairs
2 weeks ago
Navi Mumbai, Maharashtra, India Lupin Full time ₹ 25,00,000 - ₹ 45,00,000 per yearJob Description • Lead regulatory submissions for Inhalation, Nasal, Oral Solid Dosage (OSD), Contract Manufacturing, and Strategic Alliance projects for the US market.• Ensure timely and compliant responses to product deficiencies raised by US regulatory authorities, including the USFDA.• Manage post-approval submissions and annual reports for...
-
Regulatory Affairs Executive
7 days ago
Mumbai, Maharashtra, India Kryptonite Solutions Full timeCompany DescriptionKryptonite Solutions revolutionizes healthcare by delivering innovative, technology-based products that elevate hospital infrastructure and enhance patient experiences. With a focus on cutting-edge advancements, the company offers solutions such as Virtual Skylights, MRI Patient Relaxation Lines, In-Bore MRI Cinema, and Neuro Imaging...
-
Regulatory Affairs Executive
2 weeks ago
Mumbai, Maharashtra, India AMN Life Science Pvt. Ltd. Full time US$ 6,150 - US$ 7,600 per yearRegulatory Affairs Executive - Pharma IndustryLocation:KurlaCompany:AMN Life Science Pvt Ltd (EU-GMP Pharmaceutical Manufacturing -100% Export)Experience:2-3 Years |Industry:Pharmaceuticals (OSD)Reports To:Manager Regulatory affairsRole Type:Full-TimePosition Overview:We are seeking a highly motivated and experiencedRegulatory Affairs Executiveto join our...
-
Manager - Regulatory Affairs
2 weeks ago
Mumbai, Maharashtra, India Digvijaya Management Full time ₹ 6,00,000 - ₹ 18,00,000 per yearCandidate should be M.Pharmacy with 12 to 15 years of experience inRegulatory Affairs department from a reputed injectable manufacturing company,Manage regulatory affairs for injectable products, ensuring compliance with global regulations and guidelines.Develop and implement effective strategies to maintain product registrations, variations, and renewals...
-
Regulatory Affairs Associate I
1 day ago
Navi Mumbai, Maharashtra, India Teva Pharmaceuticals Full timeApply now »Regulatory Affairs Associate IDate: Nov 17, 2025Location:Navi Mumbai, India, 400706Company: Teva PharmaceuticalsJob Id: 64984Who we areTogether, we're on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It's a mission that bonds our people across nearly 60 countries and a rich,...
-
Regulatory Affairs Executive
2 weeks ago
Mumbai, Maharashtra, India Olive PharmaScience Ltd Full time ₹ 5,00,000 - ₹ 15,00,000 per yearCompany DescriptionOlive PharmaScience Ltd, an Indian pharmaceutical manufacturer with over five decades of experience, specializes in developing and manufacturing high-quality pharmaceuticals, OTC products, and dietary supplements. Renowned for its focus on advanced soft gelatin dosage forms, the company leverages its expertise in research and development...
-
Associate Regulatory Affairs Specialist
2 weeks ago
Mumbai, Maharashtra, India Akaasa Infotech Noida Full time ₹ 6,00,000 - ₹ 18,00,000 per yearJob Title: Associate Regulatory Affairs SpecialistExperience: 5+ YearsLocation: Mumbai(Hybrid mode)Job Type: 12 months contractREQUIREMENTS:5+ years supporting a regulatory or compliance organization.Experience in Regulatory Affairs or a related field, particularly within a compliance function.Hands-on experience with ETQ, RIMS, and document management...
-
Head of Regulatory Affairs
2 weeks ago
Mumbai, Maharashtra, India, Maharashtra Inventia Healthcare Limited Full timeInventia is into pharmaceutical development and manufacturing from last 40 yrs. We partner with pharma companies to research, develop, manufacture and distribute OSD. Our Manufacturing plant is in Ambernath which produces range of OSD including capsules, tablets, Granules and Pellets.We are there in 45 countries and have 10 plus facility approvals including...
-
Senior Manager Regulatory Affairs
7 days ago
Mumbai, Maharashtra, India Abreast Global Consulting Full timeRole DescriptionThis is a full-time on-site role for a Senior Manager of Regulatory Affairs based in Mumbai.Check for compliance on formulation as per FSSAI / Export/ International RegulationsLabelling in accordance with FSSAI regulations /Export/ International Regulations for products.Scrutinize and approve all labels/Artwork for conformance with all the...