Rusan Pharma Ltd. is a fully integrated global pharmaceutical company specializing in the treatment of Addiction and Pain Management. We offer a complete range of products for de-addiction and pain management in countries across the globe including Europe, UK, Russia, CIS, South Africa, Mauritius, Nepal and Myanmar. We are one of the largest suppliers of life saving drugs to various organizations such as NACO, UNODC, UNOPS, Global Fund and Ministries of health in various emerging markets.
Post : Officer / Executive for Regulatory Affairs department
Job Description
1. Responsible for Dossier compilation :
• To prepare new, renewal dossier (Semi Finished/ Finished Product) and variations (Site/ Formula) of South Asia, LATAM countries and having specific knowledge for South Africa and Brazil filing and Regulatory knowledge of Guidelines viz, ICH , FDA PICs etc.
• To review accuracy of executed data before submission - Plant generated validation reports and raw data as required to ensure compliance before Dossier submission.
• To review of documents for adequacy and accuracy.
• To ensure regulatory compliance and liaison with countries / regulatory authorities during the product registration process.
• To arrange the samples as per country requirements.
2. Responsible for Tender compilation:
• To gather, evaluate, organize, manage and collate information/ documents requirements for Tender fillings for WHO.
3. Ensure timely delivery of regulatory query:
• To review and ensure accuracy of deficiency response for Quality, Clinical part of dossier.
• To evaluate the query received for registered or under registration products and Tender products and also to support for completion of the same in timely manner.
4. Compliance (Audits / Audit Readiness)
• Support in Site Audit Readiness and Compliance relevant to RA functions / procedures based on external / internal audits.
Candidate Profile
Candidate must have prior experience in dossier preparations, review and submission for Australia / New Zealand/ Canada/ Brazil /Mexico/ CIS countries/ Europe/UK.
Additional Information
Experience : 2 to 7 year(s)
Qualification : M.Pharm, M.Sc
Location : Mumbai (All Areas)
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Regulatory Affairs
Walk in Interview
16th April, 10.00 AM - 5.00 PM
Rusan Pharma Ltd. 58-D, Government Industrial Estate, Charkop, Kandivli (W), Mumbai – 400 067
Interested candidates can share their profile at shalini.singh@rusanpharma.com
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