Coral Drugs logo

Executive / Officer - Regulatory Affairs

3 - 7 years

0 Lacs

haryana

Posted:2 weeks ago| Platform: Shine logo

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Skills Required

regulatory affairs nees rd production qc qa drug master files ectd ctd formats api process development litigation related to drugs cosmetics act filing annual updates amendments to dmfs handling queries from regulatory agencies customers technical packages of apis compliance with audits from regulatory bodies generating documents from various departments ich guidelines

Work Mode

On-site

Job Type

Full Time

Job Description

Role Overview: As a Regulatory Affairs Specialist, you will be primarily responsible for the compilation, preparation, and review of Drug Master Files (DMFs) for various markets such as US, Europe, Canada, and ROW in specified eCTD, NeeS, or CTD formats. Your role will also involve setting specifications for API process development and having knowledge of litigation related to Drugs and Cosmetics Act. Ensuring compliance with audits from regulatory bodies like USFDA and EU, as well as generating documents from departments like R&D, Production, QC, and QA for newly developed API's will be crucial. Key Responsibilities: - Compiling, preparing, and reviewing DMFs for different regions - Filing annual updates and amendments to DMFs - Handling queries from regulatory agencies and customers - Compiling, preparing, and reviewing Technical Packages of API's - Maintaining accurate records within the department - Assessing Vendor Questionnaires and relevant documents - Ensuring plant cleanliness - Conducting scheduled trainings on ICH guidelines related to the department Qualifications Required: - Minimum of 03 to 05 years of working experience in B. Pharma/M. Pharma - Location of the position: Murthal, Sonipat Additional Details: Omit as no additional details of the company are mentioned in the job description.,

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