RA Manager
Location: BelgiumSIRE 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 COMPANY
Our client is a professional Pharmaceutical organization, based in Brussel Belgium.
A veterinarian company based in Belgium, looking for to expand their business in Afrika.
ROLE DESCRIPTION
For 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.
RESPONSIBILITIES
Major Duties and Responsibilities:
Identifying new product registrations and also participating in the decision process.
Developing, maintaining and implementing a plan, acquiring the agreed new product registrations.
Cooperating with BenAfME Cluster Regulatory Affairs ensuring the regulatory plan is in line with business.
Status reports, metrics and key performance indicators, as required by the Initiative Leader.
Assisting VMRD, as required, in the preparation of product dossiers, supporting documents (certificates) and responses to questions.
Assisting icRAMs, as required, in the:
submission and follow-up of Market Access Requests (MARs); registration dossiers, certificates and product samples; questions and additional information.
Also:
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.
REQUIREMENTS
Bachelor degree in a Chemistry, Pharmacy, Biology or Veterinary Medicine related discipline, or equivalent experience.
Vocational qualifications or previous work experience may be considered to be equivalent.
At least 5 years' experience of pharmaceutical, feed additive and/or vaccine Regulatory Affairs at a national or regional level, preferably in African markets.
Ability to multi-task and to work to demanding timelines, whilst remaining focused on strategic goals.
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).
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Cees van Wezel.
