Regulatory affairs
1 week ago
Collate/prepare and file dossiers in a timely and accurate manner for Formulations and API products to get licenses from various targeted markets (Emerging Markets/ROW).
Review and regulatory impact analysis of the change control, communication with customer for notification and approval as applicable.
Review and regulatory impact analysis of the changes notified by the vendors as per current regulatory requirements (country specific), as desired.
Evaluate any changes proposed post-approval. Prepare and file necessary amendments / supplements / annual reports as applicable to ensure regulatory compliance (Post-approval Life Cycle Management).
Prepare the checklist for documentation for regulatory fillings as per current regulatory requirements (country specific).
Collate and conduct first-level review/overview of relevant standard technical documentation like stability, TTD, PDR, method validations etc. as per the country requirements.
Conduct initial review of the specifications of the API / Semi-Finished Product / Finished Product as per the regulatory requirements.
Conduct initial review of labelling/artwork as per the market where the dossier is being filed(only formulations).
e-CTD compilation/ publishing of DMF / Dossiers and Submission to customer / Health Authorities.
Assist in resolution of queries received from customer/agency/regulator and assessing them before sharing with team leader.
Sharing copies of all Agency submissions pertaining to API and Approval package for FDF,with respective manufacturing sites.
Submission of Renewals, Re-registrations, Tender (Emerging Markets).
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Regulatory Affairs Specialist
1 week 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...
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Executive Regulatory Affairs
1 week ago
Navi Mumbai, Maharashtra, India METSL Full time ₹ 3,00,000 - ₹ 4,00,000 per yearDear Candidates,We have job opportunity for the position of Regulatory Affairs Executive & QMR in our leading manufacturing Medical Devices companies.Position:-Regulatory Affairs Executive & Quality Management RepresentativeExperience:-2 to 4 yrsGender:-Male/FemaleThe JD as follows:-· Maintain regulatory files. Maintain and update regulatory authorizations,...
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Regulatory Affairs Executive
1 week ago
Navi Mumbai, Maharashtra, India METSL Full time ₹ 3,36,000 - ₹ 4,80,000 per yearDear Candidates,We have job opportunity for the position of Regulatory Affairs Executive & QMR in our leading manufacturing Medical Devices companies.Position:-Regulatory Affairs Executive & Quality Management RepresentativeExperience:-1 to 3 yrsGender:-Male/FemaleThe JD as follows:-· Maintain regulatory files. Maintain and update regulatory authorizations,...
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Regulatory Affairs
2 weeks ago
Mumbai, Maharashtra, India Actide International Full time ₹ 6,00,000 - ₹ 12,00,000 per yearJob Description:works to help a company or organization meet all state, local, federal, international, and industrial regulations that apply to their products.They must have excellent organizational, analytical, project management, and communication skills.They work frequently with other employees and team members to coordinate complex activities, often with...
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Manager - Regulatory Affairs
1 week 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...
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Drug regulatory affairs
2 weeks 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...
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Regulatory Affairs Interns
2 weeks 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...
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Regulatory Affairs Executive
1 week 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...
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Manager-Biologics Regulatory Affairs
2 weeks ago
Mumbai, Maharashtra, India USV PRIVATE LIMITED Full time ₹ 6,00,000 - ₹ 18,00,000 per yearYou will be working as an Asst Manager / Manager in the Biologics function of USV Private Limited in the Regulatory Affairs department specifically focusing on Clinical Trials for the EU and US markets. Your role will involve the following key responsibilities: - Developing Biosimilar Clinical Development Strategy, focusing on clinical trials and injectables...
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Associate Regulatory Affairs Specialist
1 week 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...