Officer - Regulatory Affairs
3 days ago
• 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 USFDA-approved products, ensuring continuous regulatory compliance and lifecycle management.
• Drive labeling updates in line with changes to Reference Listed Drug (RLD) labeling approved by the USFDA.
• Provide regulatory support for PADER (Periodic Adverse Drug Experience Reports), contributing to global pharmacovigilance and safety monitoring.
• Review and offer strategic input on documentation across product development, scale-up, and commercial manufacturing stages.
• Oversee document reviews for externally manufactured products, ensuring regulatory consistency and quality standards.
1 to 2 Years of experience in regulatory Affairs for Regulated Market
EducationGraduation in Pharmacy Masters in Science Competencies
Customer Centricity Developing Talent Collaboration Strategic Agility Process Excellence Stakeholder Management Innovation & Creativity Result Orientation
-
Regulatory Affairs Specialist
5 days 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...
-
Regulatory Affairs Executive
7 days 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...
-
Head of Regulatory Affairs
2 weeks ago
Mumbai, Maharashtra, India Inventia Healthcare Limited Full time ₹ 12,00,000 - ₹ 36,00,000 per yearInventia 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...
-
Manager - Regulatory Affairs
5 days 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...
-
Global Regulatory Affairs Specialist
2 weeks ago
Navi Mumbai, Maharashtra, India G&L Scientific Full time ₹ 12,00,000 - ₹ 36,00,000 per yearContract: Permanent Full-TimeClosing Date: 05/12/25We are seeking Global Regulatory Affairs Specialists to provide critical subject matter expertise and backfill internal SMEs during a major regulatory transformation initiative. These roles will ensure continuity of day-to-day regulatory operations - particularly across CMC, labelling, and lifecycle...
-
Drug regulatory affairs
1 week ago
Mumbai, Maharashtra, India Statistical Insights Full time ₹ 5,00,000 - ₹ 6,95,334 per yearRegulatory Affairs Specialist duties and responsibilitiesEnsuring compliance with all regulatory requirementsMaintaining regulatory documentation databaseAssisting with the preparation and submission of all regulatory reportsProviding accurate reviews of data and reportsEnsuring accurate and timely submissions to regulatory agenciesAdvising others on...
-
Head -- Regulatory Affairs
2 weeks ago
Mumbai, Maharashtra, India Inventia Healthcare Full time ₹ 12,00,000 - ₹ 36,00,000 per yearJob Title: Head Regulatory AffairsDepartment: Regulatory AffairsExperience: 20 + yearsLocation: ThaneReports To: R&D HeadPosition Summary:We are seeking an accomplished Regulatory Affairs leader with over 20 years of experience to head our global regulatory function. The ideal candidate will possess deep domain expertise in regulatory requirements across...
-
Regulatory Affairs Interns
1 week ago
Mumbai, Maharashtra, India Wellbeing Nutrition Full time ₹ 2,00,000 - ₹ 6,00,000 per yearAbout the Role:We are looking for a passionate and detail-orientedRegulatory Affairs Internto support our Regulatory team at Wellbeing Nutrition. This role offers a great opportunity to gain hands-on experience inNutraceutical and Nutrition regulatory processes.Key Responsibilities:Assist in ensuring all FSSAI licenses (NLPL, APOB) are up to dateSupport in...
-
Regulatory Affairs Executive
5 days 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...
-
Head of Regulatory Affairs
1 week 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...