Openings in Regulatory Affairs @ Unison Pharmaceuticals Ltd - PHARMA WISDOM

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Wednesday, 2 October 2019

Openings in Regulatory Affairs @ Unison Pharmaceuticals Ltd


Opening for Regulatory Affairs (AGM) at Unison Pharmaceuticals
Regulatory Affairs -Assistant General Manager
B.Sc. B.Pharm / M.Sc. / M.Pharm with 12 & above years of hands-on experience in Regulatory Affairs like Regulatory assessment at the time of New Product Development, Dossier Preparation, Dossier filling, Tender filing, Post submission to MOH (Ministry of Health), Post approval (Product Life Cycle Management and Variation filing (Notification / Minor / Major).
Job Description 
Regulatory assessment at the time of new product developmen
·         Guideline evaluation specific to the region and sharing specific requirements to F&D and ADL.
·         Support F&D team in reference product selection based on market specific requirement. positions and analysis of the existing level of competencies.
Dossier Preparation
·         Master dossier preparation
Common Technical Document (CTD)
1.  Review of modules 1 5 (Administrative, Quality Overall Summery (QOS), Quality Part (Body of Data), Non Clinical and Clinical
2.     Arrangement of Drug Master File as per regulatory requirement
Asian Common Technical Document (ACTD)
Review of parts 1 4 (Administrative, Quality Part (Body of Data), Non Clinical and Clinical
Review of Country specific dossier prepared RA team members
1.     Table of content finalization for country specific dossier
2.     Finalization of administrative part which includes; Artwork finalization, Certificate of Pharmaceutical Products, Free sell certificate, Product permission, GMP certificate, manufacturing license, Letter of access and GMP certificate from API manufactures, Declaration letter for clinical and non-clinical
3.     Finalization of Periodic Safety Update Report (PSUR)
4.     Arrangement of risk management plan through third party
5.     Arrangement of registration samples / working standards / impurities and any other requirements
Final review of dossier
Tender filing
·         Guideline evaluation specific to the region and sharing specific requirements to BD team.
·         Compile and review tender application and submit to BD team in coordination with R&D head.
Post submission to MoH (Ministry of Health)     
1.     Query response to ministry
2.     Support to Partner, Service Provider and MoH for fast approval
Post approval (Product Life Cycle Management)
1.     Verification of registration certificate
2.     Verification of export order
Variation filing (Notification / Minor / Major)
1.     Guideline assessment for variation
2.     Review of variation application according to regulatory requirement
3.     Filing of application to partner / MoH
4.     Verification of approval inline with the application
5.     Ensure revision of all related documents at plant and F&D level
Contact Person: Manisha Rajput
Interested candidates may also email their resume to career@unisonpharmaceuticals.com

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