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Sr. Executive/Assistant Manager - Regulatory Affairs

4 - 8 years

4 - 8 Lacs

Kadi Ahmedabad

Posted:1 week ago| Platform: Naukri logo

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Skills Required

Regulatory Affairs Sugam CDSCO RA

Work Mode

Work from Office

Job Type

Full Time

Job Description

Key responsibilities Prepare and submit applications via the SUGAM portal (Form 41 & 46) to relevant authorities (DCGI, IVRI, Krishibhavan, and DAHD) for veterinary products. Compile, review, and prepare CTD/eCTD dossiers for veterinary vaccines and APIs in compliance with CDSCO and international guidelines. Handle end-to-end veterinary product registration, including new applications, renewals, updates, and query responses. Track application status, follow up with authorities, and ensure timely responses to regulatory queries and deficiencies. Support audits by CDSCO and other bodies; maintain organized, inspection-ready documentation and records. Review and approve product Labelling and packaging to ensure regulatory compliance Review change control, assess PAC applicability, and prepare related submissions. Collaborate with R&D, QA, QC, Manufacturing, and Marketing to gather technical documents and provide regulatory inputs. Review technical documents and guide internal teams on regulatory standards, including new drug applications. Stay updated on evolving veterinary regulations and support the HOD in regulatory planning and decision-making. Skill Requirement Strong understanding of Indian regulatory frameworks including CDSCO. Must have experience with the SUGAM portal and CDSCO online submission process. In-depth knowledge of Form 41 and Form 46 requirements. Dossier preparation expertise for veterinary vaccines. Ability to interpret and apply regulatory guidelines accurately. Excellent communication, coordination, and project management skills. Job Location: Kadi,Gujarat (Bus transport facility available from Ahmedabad,Kalol & Kadi) Note: Immediate Joiner will be preferred first

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www.hester.com

Technology

New York

50 Employees

13 Jobs

    Key People

  • Alice Johnson

    CEO

  • Bob Smith

    CTO

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