Regulatory Affairs Specialist
On behalf of a well-known, innovative, international pharmaceutical company based in Noord-Holland, I am looking for a Regulatory Affairs Specialist. You will join a team based both in Paris and the Netherlands and will be dedicated to supporting one of the Global Business Units. The team contains 6 regulatory reviewers. This position is based in the Netherlands.
- You will review and approve promotional and non-promotional materials from all departments of the company. The goal is to ensure compliance with international regulations and company standards;
- If a material is not in compliance with international regulations and company standards, then you must explain the reason of declining the material to the creator;
- Developing, reviewing and approving promotional and non-promotional materials in collaboration with the global business units Commercial and Medical;
- Setting up guidelines for scientific information and marketing practices and defining minimum quality standards and processes to be applied globally;
- Advising the team regarding the review of promotional activities both local and worldwide;
- Contributing to complaint handling from or against competitors, globally and locally;
- You will review the regulatory aspects of internet and social media as part of the Internet Validation Committee.
In this role you will need to have
- Experience in the review of promotional and non-promotional material at affiliate, regional or global level;
- Ability to speak and understand English. Other languages are desirable;
- The ability to communicate well and to be a business partner;
- It is desirable if you have experience with Health Care Compliance or extensive knowledge of codes of practice such as CGR, EFPIA and ABPI;
- A very attractive salary (around €65.000 gross salary based on knowledge and experience);
- A bonus of 10 percent;
- Internal growth opportunities (also globally);
- The opportunity to work in a global team;
- The opportunity to work with many new product launches;
- The opportunity to contribute updating business procedures as well as the implementation of a new tool.
Are you the Regulatory Affairs Specialist I am looking for? Please contact Joey Wielkens on the number 020-5221577 or send an e-mail to j.wielkens @ realstaffing.com