Experience

Kinapse

• United Kingdom
• Pharmaceutical Manufacturing
• 100 - 200 Employee

• Senior Regulatory Consultant

  • Aug 2014 - Present

  Planning, coordinating and directing regulatory submissions for Life cycle management i.e. US Annual Reports, Renewals and variations as per regulatory requirements and internal SOPs for world’s leading innovator pharmaceutical companies. Preparing submission plans and authoring Module-1, 2 and 3 of annual reports (IND and NDA) for US, license renewals for global market and CMC Variations (Type IA, IB, II, grouped and worksharing) for EU. Subject matter expert (SME) for EU Variations and EU/EEMEA Renewals. Interaction with various health agency like EMA, MEB, MPA, and MHRA for queries related to planned submissions to have approvals right first time. Managing client projects trackers, submission management meetings with client SMEs, issue escalations and regulatory strategies. Worked on IT systems used for documents authoring, archival, product life cycle managing, tracking, planning tool, project management, Manage trainings, Publishing request, document request portals. Trainings of new team members for client process and their on boarding on job. Regulatory Intelligence- to update team members for various health author regulatory updates by internal subscribed and external web sources. People management. Show less



ELC Group

• Czechia
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Sr. Executive, Regulatory affairs

  • Oct 2013 - Jul 2014

  Preparation of registration dossiers for pharma products for EU market (In CTD & eCTD format). Preparing module 1 & 3 sections. Monitoring, interpretation, communication and implementation of new EU legislation with particular focus on generic medicines and innovator products. Preparation and Submission of dossiers via MRP/DCP/NP/CP as per eCTD format. Preparation of regulatory dossiers for repeat-use procedures. Life Cycle management (Variations and Renewals filing in eCTD / NeeS format) for various Pharmaceutical products registered in EU countries. Labelling updates Variations. Fees Calculation for various application, Interaction with different Health Agencies. Performing Gap analysis of dossier, variation package to meet acceptance criteria as per the EU regulations. Adhoc advice for clients request/queries. Show less



B. Braun Group

• Germany
• Medical Equipment Manufacturing
• 700 & Above Employee

• Executive, Drug regulatory affairs

  • Jan 2012 - Oct 2013

  Preparation of Initial registration dossiers and Life cycle management for pharmaceutical products for European countries (National procedure), Russia, Ukraine, CIS countries, South East Asian countries African countries, LATAM, Gulf countries for following types of Dosage forms. a) Parenteral Formulation: Parenteral formulation such as LVP (Large volume Parenteral) & SVP (Small volume Parenteral), ophthalmic preparations Review of CMC documents required for dossier submission. Preparation of Initial registration dossiers and Life cycle management for pharmaceutical products for European countries (National procedure), Russia, Ukraine, CIS countries, South East Asian countries African countries, LATAM, Gulf countries for following types of Dosage forms. a) Parenteral Formulation: Parenteral formulation such as LVP (Large volume Parenteral) & SVP (Small volume Parenteral), ophthalmic preparations Review of CMC documents required for dossier submission.



Kusum healthcare, delhi, india

• Pharmaceutical Manufacturing
• 100 - 200 Employee

• Executive, Regulatory affairs

  • Jun 2009 - Oct 2011

  Preparation of Initial registration dossiers and Life cycle management for pharma products for Russia, Ukraine, CIS countries, South East Asian countries (ASEAN) in CTD, ACTD & Country specific Dossier formats for following types of Dosage forms. a) Oral Formulations: Solid IR, MR formulation and Liquid dosage forms. b) Topical formulations: Semisolid dosage forms. C) Parenteral formulation: Small volume Parenteral (SVP) Review of CMC documents like Technology Transfer Documents, Product Development Report, Stability Protocols, Analytical Validation protocol & Reports, Batch Manufacturing Records and Stability data & providing the regulatory Input. Responsible for preparing SPC, PIL for Product Information and review of artwork (Label, Carton and Pack insert). Proactive co-ordination with various departments to have all documents for timely regulatory filings. Show less



Baxter, India

• Trainee

  • Jun 2006 - Aug 2006

  Two month Traning Experience Two month Traning Experience