Teva Regulatory Affairs Associate 

Netherlands, North Holland, Haarlem 

129385842

Are you passionate about contributing to the development and maintenance of pharmaceuticals and health products in the Dutch market? In this role, you’ll have the opportunity to work across all aspects of bringing a medicinal product to market and ensuring it stays compliant with regulatory requirements. You’ll have the chance to deepen your knowledge of Regulatory Affairs while working alongside a team of five seasoned professionals.

• Draft and review essential product documentation, including Summary of Product Characteristics (SPC) and patient leaflets, for pharmaceuticals, dietary supplements, medical devices and cosmetics in the Dutch market.
• Oversee and assign tasks related to product information, ensuring accuracy and compliance throughout the production of packaging materials for the Dutch market.
• Collaborate with external manufacturers, internal teams, regulatory authorities, and international representatives to gather and process product information. Maintain strong, professional relationships with all stakeholders.
• Support the registration process for products in the Netherlands, ensuring submissions comply with both national and international regulations. You’ll be responsible for compiling, updating, and adjusting registration dossiers as needed.
• Provide advice on regulatory matters, including the submission and modification of dossiers. Help develop the optimal approach to ensure regulatory compliance and successful market authorization.
• Serve as the point of contact for regulatory authorities and international representatives, providing accurate and timely responses to inquiries while protecting the company’s interests and objectives.
  

• Master’s degree in pharmacy or equivalent
• You can be a newly graduated pharmacist
• Excellent written and spoken Dutch and English are required
• Positive drive and enthusiasm with a willingness and desire to learn, grow and develop
• Attention to detail and high level of structure and accuracy
• Strong ability to organize, prioritize and cope with tight deadlines
• Ability to communicate at all levels within the organization, locally and internationally

• Candidates are required to submit a motivation letter in Dutch as part of their application. Applications without a Dutch motivation letter will not be considered.

• 25 paid holidays with 11,5 extra days (based on fulltime) with option to use for other purposes like education, cycle plan, etc.
• Competitive salary
• A number of health benefits including like Accident Assurance and Income protection
• 9 weeks of fully paid parenteral leave
• Flexible working conditions with hybrid working policy
• Competitive Pension

Ivo Huijskens - Senior Recruiter Europe

Senior Manager Regulatory Affairs

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.