Well established and continually expanding, Chemilines are recognised as one of the UK's leading pharmaceutical importers and distributors of sourced branded medicines, generics and perfumes in the UK. In Southern Ireland, Chemilines is a major distributor of branded fragrances and over the counter products.
Post: Regulatory Affairs Manager
Job Description:
Responsibilities:
To participate in all aspects of the work of Regulatory Affairs department:
• Preparation and submission of New licence applications
• Preparation and submission of licence variations/renewals
• Preparation of labels/leaflets
• Design and Inspection of Batch Processing Records
• Having Knowledge about GMP, WHO GMP, Manufacturing Licence, Product Licence, COPP, FSC, attestation of documents from various embassies.
• Having Knowledge about BE and eCTD, MHRA submission.
• Review, submission of quality dossiers as per the current guideline (country specific)
• Collection of dossier documents from various departments like QC, QA, Stores, Production, FD, Stability and maintaining in a master document with systematic manner.
• Coordinating with HQ for the submission of Quality Dossiers and to reply the response for the queries.
• Collection of DMF from suppliers for dossier preparation.
• Supporting clinical Pharmacokinetic, Physiological properties Bioavailability, BE published document for dossier preparation.
• To deal efficiently and effectively with all regulatory agencies for various regulatory policies and issues.
• Scrutiny and internal regulatory Audits of Quality system as per guidelines and SOPs
Desired Profile:
• Having Knowledge about GMP, WHO GMP, Manufacturing Licence, Product Licence, COPP, FSC, attestation of documents from various embassies.
• Having Knowledge about BE and eCTD, MHRA submission.
Additional Information:
Exp: 2-5 yrs
Location: Ahmedabad
Education: B.Pharm, M.Pharm, B.Sc, M.Sc
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: R&D
End Date: 23rd June, 2011
Forward your resume at, arun.saklecha@chemilines.com
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