Actively seeking New Opportunities...• Over 5 years of core experience in Regulatory Affairs (RA) department in pharmaceutical industry for regulated market with expertise in overall medicinal product registration for whole product registration cycle• Major area of expertise in regulatory dossier preparation, CMC writing of dossier, regulatory project management, submission to health regulatory agencies and product life cycle management• Ability to work proactively across teams and participate as team player in all cross-functional tasks required for product registration as well as its life-cycle management• Development and implementation of Regulatory Strategy in context with regulatory compliance as well as in best possible along way with business need• Focus in continuously seeking, promoting and implementing ways to improve registration dossier content• Involvement in preparation of responses to queries with Health Agencies throughout the product life cycle• Well-versed in monitoring and in communication to health authorities for all regulatory filings status throughout the submission cycle• Co-ordination in providing regulatory inputs for Health Agency Audits as well as in assisting in drug recall and other quality attributes• Ability to perform in initiation and assisting Change Control procedures and SOP administration• Involvement in reviewing of release product compliance with regards to cGMP and regulatory scope• Expertise in compilation of precise dossier content in eCTD/NeeS format and capable of using eCTD publishing software and project management software• Well-aware of current regulatory environment and guidelines for Health Canada/EMEA (Europe), ICH Guidelines in context with regulatory compliance and quality assurance• Well acquainted computer skills including utilization of all required software (MS Word, Adobe, MS Excel, MS PowerPoint, MS Outlook)
Listed skills include Regulatory, Business Development, Pharmaceutical Industry, Regulatory Affairs, and 7 others.