Experience

Maneesh Pharmaceuticals Limited

• Spain
• Pharmaceutical Manufacturing
• 100 - 200 Employee

• Assistant Manager Regulatory Affairs

  • Oct 2017 - Present

  1.Submission of regulatory documents/Dossiers in various countries like South Africa,Mexico, Philippines, Vietnam, Kenya, Cambodia, Cuba, Guyana, Sri Lanka, Congo, Nigeria, Ghana, Togo, Jamaica, Zambia, Dominican Republic, Korea, Tajikistan, Benin etc.2.Query handling from Authorities of ROW market.3.Preparation of Dossiers in CTD format. (Module-1, Module-2, Module -3, Module -4& Module -5)4.Preparation of Dossiers in ACTD format. (Part I, Part II, Part III, Part IV)5.Preparation of DMF (Drug Master File) in CTD format.6.Drug registration with semi regulated countries7.Overview of Analytical Method Validation8.Preparation of protocol of formulation Development & Process Validation9.Preparation of stability data protocol as per ICH guideline.10.Documents checking for Regulatory submission11.Keeping updates of international legislation, guidelines and customer practices in allcountries that the company is exporting to;12.Collecting and evaluating scientific data that has been researched by colleagues13.Writing clear, accessible product labels and patient information leaflets14.Specifying storage, labeling and packaging requirements



Arem Pharma

• Regulatory Affairs Executive

  • Dec 2009 - Sep 2017