Regulatory Affairs Specialist

Dentsply Sirona

DS is seeking a dynamic, collaborative advisor with excellent knowledge of existing regulatory environment for dental products in Turkey. Candidates must demonstrate the ability to analyze regulations for impact on the company and the company’s products. A demonstrated ability to communicate complicated regulatory issues cross functionally is a must. 

• Manage governmental inquiries and communications including product registrations and licencing
• Manage the regulatory review of marketing and sales materials, including labels and labeling, advertising,
• Product claims, and packaging requirements for compliance
• Manage DS’s intellectual property portfolio. Manage litigation, oppositions and trademark strategy.
• Review and draft contracts; vendor, supplier and customer contracts. Draft NDAs, ICAs and other agreements as needed.
• Maintain a system to receive product registration requests, prepare product registrations and follow up on post submission activities.
  

Specifically :

• Review registrations requests received from SBUs/ RCOs for completeness and provide feedback on completeness of requests
• Prioritize registration requests and communicate to stakeholders
• Prepare regulatory submissions
• Provide any additional information required by coordinating with the SBU ( Strategic Business Unit)
• Build intelligence in terms of efforts, cost and time required to register the products by country and product type
• Update applicable tracking systems to provide real time update on status of registration requests and re-registrations
• Track re-registration requirements and submit as necessary

JOB DESCRIPTION

• Ability to manage multiple priorities 
• Ability to leverage on available resources
• Strong relationship building skills and high level of personal accountability
• Strong Interpersonal communication skills
• Conflict resolution skills in complex management organization
  
• Internationally oriented, culturally sensitive
• Experience interactiong with Ministries
  
• Expert level :Microsoft Outlook, Word, Excel and Power point
• Experience in quality/regulatory in life sciences, preferably in medical devices
  
• Experience interacting with international regulatory agencies for product registrations.
• Ability to work effectively through influence and relationships building