Executive / Officer Regulatory Affairs
Job Description
Posted:
September 2024
### Key Responsibilities:
• Compilation, preparation, and review of DMFs for US, Europe, Canada and ROW markets in specified eCTD or NeeS or CTD formats.
• Setting specifications of API process development, knowledge of litigation related to Drugs and Cosmetics Act.
• Filing annual updates and amendments to various regions of submitted DMFs.
• Handling queries obtained from different regulatory agencies and customers.
• Compilation, preparation and review of Technical Package of API's.
• Compliance to audits of regulatory bodies especially USFDA and EU.
• Generation of documents from R&D, Production, QC and QA of newly developed API's.
### Administrative Duties:
• Responsible for record keeping and to ensure correctness of records pertaining to department.
• Responsible for all type of computer work and follow-ups.
• Carrying out the initial assessment of Vendor Questionnaire and relevant documents.
• Maintain housekeeping and cleanliness of plant.
• To impart scheduled trainings of ICH guidelines pertaining to department.
### Job Requirements:
• Desirable: Minimum 03 to 05 years working experience B. Pharma/M. Pharma
• Location: Murthal, Sonipat.
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Job Detail
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Job IdJD3531934
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IndustryNot mentioned
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Total Positions1
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Job Type:Full Time
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Salary:Not mentioned
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Employment StatusPermanent
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Job LocationHR, IN, India
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EducationNot mentioned
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ExperienceYear