Regulatory Affairs Sr Executive - Ahmedabad, Gujarat

CTD/ ACTD · Process Validation (PV) · Stability · PDR · ...

We are looking for a Regulatory Affairs Executive who will assist in the preparation of registration dossiers handle export regulatory documentation and manage CIB & RC-related activities for agrochemical products. · Assist in preparation submission and follow-up of CIB & RC doss ...

Qualification : Postgraduate or equivalent in Pharma/Medical Devices domain · Reports to: Head of RA / RA Manager · About the role: · We are seeking experienced candidates to join our dynamic team in the Quality Assurance / Regulatory affairs, in the field of class III / class ...

The Regulatory Affairs Executive will be responsible for supporting Business Development Managers on product-related queries from India and coordinating audits of supplier production facilities to ensure compliance with international standards. · ...

We are looking for a Regulatory Affairs Executive who will assist in the preparation of registration dossiers, · handle export regulatory documentation, · and manage CIB & RC–related activities for agrochemical products.Assist in preparation, · submission, · & follow-up of CIB & ...

Assist in preparing and managing documentation for specification setting, · change controls, regulatory submissions, annual product reviews · ,and investigations with suppliers. Ensure timely completion of · regulatory submissions and strict adherence to quality standards. · Bac ...

Role & responsibilities · Preparation of Financial Models for Tariff Petitions. · Drafting of Tariff Petitions, Replying to queries of GERC/JERC/CERC related to Tariff Petitions · Analysis of Miscellaneous Petitions/Orders of different distribution licensees related to Tariff · D ...

+Job summary · Responsible for CTD/eCTD dossier preparation and compilation. Handle product registrations, variations, deficiency responses, lifecycle management, labeling and coordination with QA, QC, · +ResponsibilitiesCTD/eCTD dossier preparation and compilation · ...

The Regulatory Affairs Officer is responsible managing regulatory documentation and submissions in compliance with CTD dossier requirements. · ...

PMT Nutraceuticals is hiring a Regulatory Affairs – Executive to manage regulatory compliance and product registrations across ROW markets. · ...

This role is ideal for individuals who are keen on working with a dynamic team for having hands-on work experience in global education and research, cross-cultural communication, administration and management. · This role provides an opportunity to join a globally experienced tea ...

Ensure that a company's products comply with the regulations of the regions where they want to distribute them. · ...

We are hiring a highly experienced Senior Regulatory Affairs Executive for our pharma company in Ahmedabad. The role involves dossier preparation & submission (CTD/ACTD/eCTD), product registration, regulatory strategy, compliance with WHO-GMP/ICH/global guidelines and handling RO ...

The Regulatory Affairs Executive will be responsible for preparation and compilation of dossiers for ROW / Africa markets, · handling regulatory submissions, · ensuring compliance with regulatory guidelines & documentation standards.Preparation and compilation of dossiers (CTD Mo ...

Company Description · VIHARSH LIFE SCIENCE PVT LTD is a growing pharmaceutical company based in Ahmedabad, Gujarat, India. The organization specializes in the marketing pharmaceutical products as well as providing regulatory services on a global scale. With a commitment to qualit ...

The company seeks an International Regulatory Affairs Executive to prepare product dossiers and respond to regulatory queries. · ...

Compile and submit ANDA submissions and amendments to FDA with an overall objective to avoid major deficiencies and contribute to get approval within the shortest timeframes possible. · ...

Senior Executive in Regulatory Affairs with expertise in Sterile dosage forms ANDAs either with Aseptic sterilization or Terminal sterilization or both techniques. · ...

+Compile, prepare, review and submit ANDA submissions and Amendments to FDA with an overall objective to avoid major deficiencies and contribute to get approval within the shortest timeframes possible. · +Maintains full awareness of all regulatory activities on assigned projects ...

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Compile and submit ANDA submissions to FDA to avoid major deficiencies and contribute to get approval within the shortest timeframes possible. · ...