Experience

Sun Pharmaceuticals

• India
• Pharmaceutical Manufacturing
• 300 - 400 Employee

• Research Manager

  • Oct 2018 - Present

   Thorough knowledge of EMA, FDA, MHRA, EMA, SAHPRA, GCC, NPRA, PPB regulatory guidelines Manage the work flow of the department, such as coordinating with various other sector of the company by asking their requirement and then distribution of that work considering the potential, expertise and hierarchy of the person with adhering to timeline without affecting the filing date. Respond to the queries raised by the various regulatory authorities such as USFDA, MHRA, EMA, SAHPRA, GCC, NPRA, PPB etc. Excellent skills in literature search Preparation of protocol, clinical study report, and other study related documents Preparation of patient safety narratives of adverse events observed in clinical study Manuscript writing, Systematic review/Meta-analysis Preparation of pre-clinical sections of the marketing authorisation dossier (Module 2.4 and 2.6) Preparation of clinical sections of the marketing authorisation dossier (Module 2.5 and 2.7) Preparation of the informative texts (SmPC, PIL, PI) of the marketing authorisation dossier Preparation of preclinical and clinical expert statements Handling of response phases during a marketing authorisation procedure Preparation of further preclinical and clinical documents relating to marketing authorisation of a medicinal product (e.g. applications for orphan medicinal product designations, environmental risk assessments, paediatric investigation plans) Preparation of other medical-scientific documents (e.g. publications, product rationales, medico-marketing material) Release the document after final QC to various health authorities Prepare and review the various SOPs which are needed by the department timely to update the standards Any other reasonable tasks that are corresponding to abilities, if asked



PharmaLex

• Germany
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Assistant Manager

  • Mar 2015 - Oct 2018

   Preparation of pre-clinical sections of the marketing authorisation dossier (Module 2.4 and 2.6) Preparation of clinical sections of the marketing authorisation dossier (Module 2.5 and 2.7)  Preparation of pre-clinical sections of the marketing authorisation dossier (Module 2.4 and 2.6) Preparation of clinical sections of the marketing authorisation dossier (Module 2.5 and 2.7)