Executive / Officer - Regulatory Affairs Coral Drugs
Coral Drugs
Office Location
Full Time
Experience: 3 - 3 years required
Pay:
Salary Information not included
Type: Full Time
Location: Haryana
Skills: compilation, Preparation, Review, NeeS, Record Keeping, DMFs, eCTD, CTD formats, API process development, Litigation related to Drugs, Cosmetics Act, Filing annual updates, Handling Queries, Technical Package of APIs, Compliance to audits, Generation of documents, Computer work, Vendor Questionnaire assessment, ICH Guidelines
About Coral Drugs
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.,