Netherlands Job Openings
Teva Pharmaceuticals
Regulatory Affairs Associate
Haarlem
FULL TIME
September 12, 2024
- 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.
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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
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