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Executive/Sr. Executive (Regulatory & Affairs) - (For Shinil Pharma Ltd.)-Job ID: 1422348

Posted: 14 hours ago

Job Description

Shinil Pharma Ltd. is looking for Executive/Sr. Executive (Regulatory & Affairs)Job Description / ResponsibilityPrepare, compile, and submit dossiers for new product registration, re-registration, and variations to the relevant regulatory authorities (DGDA, WHO, FDA, GLP, etc.).Maintain up-to-date knowledge of local and international pharmaceutical regulations, guidelines, and requirements.Ensure compliance of product labeling, packaging, and promotional materials with regulatory standards.Liaise with cross-functional teams (R&D, QA, Production, Marketing) to collect technical documents for submission.Monitor the progress of regulatory submissions and proactively follow up with authorities to expedite approvals.Maintain proper documentation and regulatory database to ensure timely renewals and approvals.Support audits, inspections, and respond to queries from regulatory bodies.Provide regulatory intelligence to management regarding new policies, amendments, or guidelinesEducational RequirementsBachelor of Pharmacy (B.Pharm)Master of Pharmacy (M.Pharm)Bachelor of Science (BSc) in ChemistryBachelor of Science (BSc)Skills Required: Drug Regulatory AffairsExperience Requirements2 to 4 year(s)The applicants should have experience in the following business area(s):Pharmaceutical/Medicine Companies,Livestock,Animal/Plant BreedingAdditional RequirementsKnowledge of national (DGDA) and international regulatory guidelines (ICH, WHO, FDA, EMA) preferred.Strong documentation, analytical, and communication skills.Job LocationDhaka (Naya Paltan)

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