Experience

FINORION PHARMA INDIA PRIVATE LIMITED

• India
• 1 - 100 Employee

• Assistant Manager

  • Aug 2015 - Present

  • Development of global regulatory strategies and submissions of marketing authorizations, variations in Europe (via National/MRP/DCP/Centralized Procedures) & Emerging markets.• CMC Review and writing • Compilation of Drug Product dossier in eCTD/CTD formats.• Life cycle management of existing MAA's. • Good knowledge and understanding of ICH, EU guidelines and European procedures.• Expertise in Document management systems like ENOVIA and PALLAS and Publishing Tools.• Expertise in performing detailed needs assessment leveraging marketing analysis, stakeholder, corporate requirements, regulatory guidelines and other relevant information to design comprehensive plans.• Good communication, presentation & interpersonal skills with proficiency at grasping new concepts quickly & utilize the same in a productive manner.• Rich relationship skills, leadership and influencing - able to influence without authority and commands respect through actions – and ability to manage conflict• Part of project team for new Regulatory Information Management System to be implemented in the organization.• Participation in RIMS business case preparation, vendor selection and proof of concepts phase. Show less

• Regulatory Affairs Executive

  • Aug 2015 - Aug 2015

  -Development of global regulatory strategies and submissions of marketing authorizations, variations in Europe (via National/MRP/DCP/Centralized Procedures) & Emerging markets.-Provide guidance and support to businesses on regulatory policies and procedures; ensure internal compliance with regulatory requirements; and prepare submissions and filings with regulatory bodies.-Compilation of Drug Product dossier in eCTD/CTD formats.-Good knowledge and understanding of ICH, EU guidelines and European procedures. Show less



Bristol Laboratories Limited

• United Kingdom

• Regulatory affairs-officer

  • Jul 2014 - Jul 2015

  Compilation and submission of the variation packages through electronic submission (NeeS and eCTD). Preparation and review of the Product License Files based on the initial application and variation approvals. Artwork management: preparation, review and approval of the artworks for variations and initial submissions. Compilation and submission of the variation packages through electronic submission (NeeS and eCTD). Preparation and review of the Product License Files based on the initial application and variation approvals. Artwork management: preparation, review and approval of the artworks for variations and initial submissions.