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 . 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).