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Regulatory affairs specialist - medicines

Lasne
beBee Careers
Publiée le 13 juin
Description de l'offre

The Regulatory Affairs Manager occupies a pivotal position within the organization, providing critical opinion and communication on issues impacting members. This role requires close collaboration with other Regulatory Affairs Managers to support members' needs in areas such as law interpretation, new laws, product notification, advertising claims, price files, medical complaints, brand names, European regulations, national regulations, and more.


Responsibilities

* Advise on new policies and legislation at national and European levels
* Participate in RA meetings with authorities, associations, and stakeholders to represent member interests and collect information
* Organize internal working groups to explain new trends and laws to members and shape their best position

This is an ideal opportunity for a flexible part-time or full-time employee who can dedicate minimum 60% of their time to this role. The successful candidate will have a scientific university degree, ideally in pharmacy (Master), and previous experience in Regulatory Affairs, preferably with OTC products. A strong network within the industry and with authorities is also highly valued.

The ideal candidate should be fluent in Dutch, French, and English, both written and spoken, and possess knowledge of Microsoft Office. They should also be a team player, dynamic, autonomous, well-organized, diplomatic, flexible, and proactive. Additionally, they should demonstrate a strong commitment to achieving agreed objectives and understand how decisions are taken within the pharmaceutical industry.


About the Role

This position offers a unique opportunity to work in a dynamic environment where decisions are approached from a legislative perspective. The Regulatory Affairs Manager will have direct and indirect influence on the external environment, explaining members' needs and expectations.


About the Industry

The over-the-counter (OTC) medicines and healthcare products industry plays a vital role in promoting recognition of the socio-economic role of these products, taking into account the interest of public health, healthcare professionals, and the association's member companies.


What We Offer

This role presents an exciting opportunity to contribute to a social and political climate favorable to self-care, where the patient-consumer occupies a central position.

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