Regulatory Affairs Manager
2 days ago
Job Description About the client: PSS has been mandated to hire a Regulatory Affairs Manager for one of the leading pharmaceutical companies in India. Job Purpose To register Formulation products in the European markets, handling all submissions and taking care of all queries. Key Responsibilities - The candidate should have sound knowledge of all Regulatory Filings, be well-versed in e-CTD, Dossier submissions, be familiar with ICH guidelines, handled Educe dossier management and Lorange Doc bridge software for eCTD compilation and publishing. - Preparation of quality dossier (eCTD, CTD, ACTD, and Checklist) with regulatory compliance with respect to country requirements. - Preparation of e-CTD dossier submission by using educe, track-wise. - Review of technical documents such as BMR, Process Validation Report, Analytical Method Validation Report, Stability Study Report, and all other documents pertaining to product registration. - Checking and developing text matter in Artworks (i.e. leaflets, carton & foil) as per requirement, such as specific storage conditions. - Review of Dossiers, Responsibility for Compilation of Dossiers. - Coordination in query response after regulatory submission. Synchronize with various departments (production, quality control, quality assurance, R & D, and F&D) to collect required input for timely regulatory submission of products. Educational Qualifications And Experience - The candidate should have a B Pharm or M Pharm degree. - Age up to 38 years. - A minimum of 10 to 15 years of overall experience in Regulated Markets, - Especially European markets
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Regulatory Affairs Manager
2 weeks ago
Delhi, India Wembrace Biopharma Private Limited Full timeJob Description Job Profile The Regulatory Affairs Manager (RAM) for Africa, MENA, and LATAM will lead regulatory strategy, submissions, approvals, and life-cycle management of pharmaceutical, biotech, and nutraceutical products across these diverse regions. The role requires a strong understanding of local health authority requirements, WHO guidance, and...
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Regulatory affairs manager
3 weeks ago
New Delhi, India Self-employed Full timeCompany Description Founded in the commercial operations year of , Next Gen Pharma, a majority-owned subsidiary of Ormendes SA, Switzerland, has emerged as a leading provider of specialized botanical and nutraceutical solutions. With a focus on proprietary Targeted Bacterio-Therapy (TBT), our offerings cater to diverse therapeutic segments ranging from...
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Regulatory Affairs Manager
3 weeks ago
New Delhi, India Self-employed Full timeCompany DescriptionFounded in the commercial operations year of , NextGen Pharma, a majority-owned subsidiary of Ormendes SA, Switzerland, has emerged as a leading provider of specialized botanical and nutraceutical solutions. With a focus on proprietary Targeted Bacterio-Therapy (TBT), our offerings cater to diverse therapeutic segments ranging from...
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Regulatory Affairs Manager
4 weeks ago
New Delhi, India Self-employed Full timeCompany DescriptionFounded in the commercial operations year of 2015-16, NextGen Pharma, a majority-owned subsidiary of Ormendes SA, Switzerland, has emerged as a leading provider of specialized botanical and nutraceutical solutions. With a focus on proprietary Targeted Bacterio-Therapy (TBT), our offerings cater to diverse therapeutic segments ranging from...
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Regulatory Affairs Manager
3 weeks ago
New Delhi, India Self-employed Full timeCompany Description Founded in the commercial operations year of , NextGen Pharma, a majority-owned subsidiary of Ormendes SA, Switzerland, has emerged as a leading provider of specialized botanical and nutraceutical solutions. With a focus on proprietary Targeted Bacterio-Therapy (TBT), our offerings cater to diverse therapeutic segments ranging from...
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Regulatory Affairs Manager
4 weeks ago
New Delhi, India Self-employed Full timeCompany DescriptionFounded in the commercial operations year of 2015-16, NextGen Pharma, a majority-owned subsidiary of Ormendes SA, Switzerland, has emerged as a leading provider of specialized botanical and nutraceutical solutions. With a focus on proprietary Targeted Bacterio-Therapy (TBT), our offerings cater to diverse therapeutic segments ranging from...
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Regulatory Affairs Manager
2 weeks ago
New Delhi, India Self-employed Full timeCompany Description Founded in the commercial operations year of , NextGen Pharma, a majority-owned subsidiary of Ormendes SA, Switzerland, has emerged as a leading provider of specialized botanical and nutraceutical solutions. With a focus on proprietary Targeted Bacterio-Therapy (TBT), our offerings cater to diverse therapeutic segments ranging from...
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Regulatory Affairs Manager
1 week ago
New Delhi, India Self-employed Full timeCompany Description Founded in the commercial operations year of , NextGen Pharma, a majority-owned subsidiary of Ormendes SA, Switzerland, has emerged as a leading provider of specialized botanical and nutraceutical solutions. With a focus on proprietary Targeted Bacterio-Therapy (TBT), our offerings cater to diverse therapeutic segments ranging from...
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Regulatory Affairs Manager
1 day ago
Delhi, Delhi, India Ace Cathtech Pvt. Ltd. Full time ₹ 6,00,000 - ₹ 9,00,000 per yearCompany DescriptionAce Cathtech Pvt Ltd, established in April 2024, is a cutting-edge manufacturer of premium medical devices, specializing in Nephrology Products, Cardiac Surgery Equipment, Critical Care, and Anesthesia Products. Located in Faridabad, Haryana, our state-of-the-art facility adheres to the highest manufacturing standards, including a Class 7...
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Executive - Regulatory Affairs
2 weeks ago
Delhi, Delhi, India Domnic Lewis Pvt. Ltd Full time**Executive - Regulatory Affairs - Delhi**: **Domnic Lewis has been mandated to hire for Executive - Regulatory Affairs - Delhi** **Position Title**: Executive - Regulatory Affairs **Grade**: C **Reports to**: Lead/Manager - Regulatory Affairs **Position Purpose**: - Monitor and report the status of all product licenses in a timely and accurate manner -...
