Türkiye
Markets (TR, EU, US FDA, Canada, MENA Countries, CIS Countries, Balkans Countries, Gulf Countries, South& North Africa) Extensive knowledge of regulatory procedures and legislation for product registration, line extension, license maintenance and approval processes for 50 export countries and regular markets (US-FDA, EU, Swissmedic , New Zealand, Middle East and North Africa (MENA), South Africa, CIS, Balkans and Gulf Contries) - Create and develop product positioning strategies based upon regulatory requirements for multi-country regulatory strategies and update based upon regulatory changes - Define Regulatory Affairs strategy including pricing and reimbursement in line with the corporate and business strategies - Ensure compliance with product post marketing requirements - Review and approve advertising and promotional items for regulatory compliance - Develop solutions to address issues with other members of management and stakeholders - Provide strategic guidance for product development and planning throughout the product lifecycle - Analyze regulatory guidelines, policies and actions to determine regulatory and legal impact on the company - Advise stakeholders of regulatory options and recommend solutions - Generate timely, complete and accurate updates - Conduct and present regulatory due diligence - Provide training for sales team on current and new promotional activity guidelines to ensure company-wide compliance - Represent regulatory affairs in product recall and recall communication process
Markets (EU, US FDA, Canada, MENA Countries, CIS Countries, Balkans Countries, Gulf Countries, South& North Africa) Extensive knowledge of regulatory procedures and legislation for product registration, line extension, license maintenance and approval processes for 50 export countries and regular markets (US-FDA, EU, Swissmedic , New Zealand, Middle East and North Africa (MENA), South Africa, CIS, Balkans and Gulf Contries) - Create and develop product positioning strategies based upon regulatory requirements for multi-country regulatory strategies and update based upon regulatory changes - Define Regulatory Affairs strategy including pricing and reimbursement in line with the corporate and business strategies - Ensure compliance with product post marketing requirements - Review and approve advertising and promotional items for regulatory compliance - Develop solutions to address issues with other members of management and stakeholders - Provide strategic guidance for product development and planning throughout the product lifecycle - Analyze regulatory guidelines, policies and actions to determine regulatory and legal impact on the company - Advise stakeholders of regulatory options and recommend solutions - Generate timely, complete and accurate updates - Conduct and present regulatory due diligence - Provide training for sales team on current and new promotional activity guidelines to ensure company-wide compliance - Represent regulatory affairs in product recall and recall communication process
Markets (TR, EU,Canada, MENA Countries, CIS Countries, Balkans Countries, Gulf Countries, South& North Africa)
Markets (EU, US FDA, Canada, MENA Countries, CIS Countries, Balkans Countries, Gulf Countries, South& North Africa)
Markets (Turkey, EU, US FDA, Canada, MENA Countries, CIS Countries, Balkans Countries, Gulf Countries, South& North Africa)