Senior Regulatory Affairs Executive Lywo Hyderabad

7.0 - 12.0 years

5 - 10 Lacs

visakhapatnam

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We are looking for a meticulous Senior Executive or Assistant Manager to lead regulatory filings at Synnat Pharma Pvt Ltd, a rapidly expanding company in the Active Pharmaceutical Ingredient (API) industry. In this pivotal role, you will be instrumental in navigating the complex landscape of pharmaceutical regulations, ensuring our API products meet the stringent requirements of global regulatory bodies, particularly the US FDA. Your expertise will be crucial in preparing and submitting Drug Master Files (DMFs) and eCTD-compliant documentation, managing regulatory inspections, and proactively mitigating regulatory risks. You will collaborate closely with API manufacturing, quality control, a...

Posted 2 months ago

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Executive/Sr.Executive- Regulatory Affairs (API) Biophore

3.0 - 6.0 years

2 - 6 Lacs

Hyderabad

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Dear All, Greetings from Biophore !! This is an opportunity with Biophore in Regulatory affairs -API Department . Please go thorough the JD. Interested candidates share your CV's to "recruitments@biophore.com". Location : Pashamylaram, Patancheruvu . Job description : Roles and Responsibilities DMF submissions, Annual Reports, Variations, Renewals etc. for US and Europe market. Compilation and publishing in eCTD/CTD format for Submission to health agencies like EDQM, USFDA etc. Oversee final technical quality review and technical validation (PDF/eCTD/NeeS) Review all regulatory agency submission materials for accuracy, comprehensiveness, or compliance with regulatory standards. Provide defic...

Posted 5 months ago

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Research And Development Manager Glochem Industries

5.0 - 10.0 years

6 - 10 Lacs

Hyderabad

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We are looking for a meticulous Assistant Manager R&D to spearhead API development initiatives at Glochem Industries. As Assistant Manager, you will play a crucial role in executing complex organic syntheses, optimizing reaction conditions, and assisting in the development of scalable and environmentally friendly synthetic routes for API manufacturing. Your responsibilities will span from meticulous documentation of experimental procedures and results to collaborating with cross-functional teams, including analytical, kilo lab, and pilot plant teams, for sample analysis and process scale-up. The ideal candidate will have a strong foundation in organic chemistry, a deep understanding of API m...

Posted 5 months ago

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