Regulatory Affairs Manager

Bedrijfsnaam: -
Plaatsingsdatum: 30/09/2018
Standplaats: -


SIRE® 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 Flandre Orientale Belgium.The CompanyOur client is a big pharmaceutical company, based in East Flanders, Belgium. They are a leading supplier of generic pharmaceuticals, both human and veterinary medicines. The are currently looking for a new regulatory manager.

Role DescriptionAs the regulatory manager, you will be in charge of the regulatory affairs in collaboration with internal and external partners. By supervising the team of specialists, you ensure the timely execution, efficiency and effectiveness of the regulatory processes

ResponsibilitiesPlan, coordinate and supervise all regulatory related activity
Responsible for registration procedures to obtain registration
Variations and renewals of existing registrations
Contribute to regulatory strategy
Communication with (local) authorities
Pharmacovigilance documentation
Translations, SOP preparation
Responsible for Information and Publicity

RequirementsDegree in Industrial Pharmacy or something life sciences related
Around 5 years of experience in Regulatory Affairs Management in an international context
QPIP status is highly desired
Fluent in English, French and Dutch
Pharmacovigilance experience
Knowledge of regulatory procedures and relevant legislation
Experience working with Belgian authorities
Good communication, relationship and presentation skills

Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Nicolas Gyselinck.




Plaatsingsdatum :
Referentienummer :
Standplaats :
Adres :
Postcode :
9723 HK
Opleidingsniveau :
Uren :
Nader te bepalen
Dienstverband :
Werkervaring :
3 - 5 jaar
Contactgegevens :