SIRE Life Sciences® is the market leader in life science recruitment. We believe the recruitment market needs to gear up in technology and continues innovation. We like technology, in a life science 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!
The companyOur client is a professional Pharmaceutical organization, based in Overijssel Netherlands. Looking to develop business in Afrika this veterinarian pharmaceutical company is pushing the standards of modern medicine.
Role descriptionFor an upcoming livestock initiative in Sub-Saharan Africa, the company is looking for a Regulatory Affairs Manager - 1 to 3 year project. Primary location will be in the Brussels area with less than 10% travel.
ResponsibilitiesMajor Duties and Responsibilities:
Assist VMRD, as required, in the preparation of product dossiers, supporting documents (certificates) and responses to questions.
Assist icRAMs, as required, in the:
submission and follow-up of Market Access Requests (MARs); registration dossiers, certificates and product samples; questions and additional information.
Compilation, translation and submission of registration dossiers; Preparation and/or approval of product labels and package inserts; Registration dossiers, certificates and product samples compilation, translation and submission of registration dossiers, as required.
Identify novel product registrations and participate in the decision process.
Develop, maintain and implement a plan, acquiring the agreed product registrations.
Cooperate with BenAfME Cluster Regulatory Affairs to ensure the regulatory plan is in line with the business.
RequirementsMaster degree in a related discipline, or equivalent experience.
At least 5 years' Regulatory Affairs experience at a national or regional level, in African markets.
Ability to work with and lead matrix teams.
Ability to negotiate to obtain necessary resources and technical support to address project/product needs.
Demonstrated competence in MS Word, Excel and PowerPoint.
Excellent communication skills (written and spoken English).