Regulatory Affairs Manager OTC
Location: BelgiumSIRE® is the market leader in Life Sciences recruitment. We believe the recruitment market needs to gear up in technology and continuous innovation. We like technology, in a Life Sciences market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!Our client is a professional Pharmaceutical organisation, based in Antwerpen Belgium.
You will be part of a team of several R&D project leaders that work on projects in dermatology, cough & cold, insect & parasite control and other OTC indications.
Oversee all contacts with the notified bodies, regulatory authorities and have final technical file responsibility.
In addition, you cooperate with the R&D drug development team on the preparation of new marketing authorization applications.
- Comitted colleague with a clear head for problem solving
- Fluency in English is a must
The Company
An OTC company with a strong focus on R&D and innovation. Always developing new Consumer Health Products (OTC) to bring non-prescription health products to the market. Always dombining science with consumer preference.Role Description
A Regulatory Affairs senior manager that coordinates the regulatory affairs in medicinal products, medical devices and dietary supplements.You will be part of a team of several R&D project leaders that work on projects in dermatology, cough & cold, insect & parasite control and other OTC indications.
Responsibilities
The ideal candidate is an experienced regulatory affairs specialist with an excellent background in medical devices and prescription free drugs, preferably in a consumer health care setting. Knowledge of dietary supplement law is an additional asset.Oversee all contacts with the notified bodies, regulatory authorities and have final technical file responsibility.
In addition, you cooperate with the R&D drug development team on the preparation of new marketing authorization applications.
Requirements
- Autonomous professional with excellent project management skills- Comitted colleague with a clear head for problem solving
- Fluency in English is a must
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