Regulatory Affairs Specialist - Belgium
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We are looking for a Regulatory Affairs Specialist with experience in Pharma CMC.
- Management and update of the pharmaceutical part of the worldwide registration dossiers on the finished products
- Answers questions from the Health Authorities worldwide
- Elaboration of variations to make changes to the registration dossiers
- Responds to queries from the subsidiaries , manufacturing plants and various departments within the company
- The department is responsible for all CMC(Chemistry-Manufacturing and Control)-aspects of the production of medicines (development – production techniques – analysis of the product- specifications –packaging components -stability until the end phase/expiration date of the medicine) sections of the registration dossiers
- Registration of products in new markets
- Preparation of variations
- Updating registration dossier sections
- Responds to questions from the Health Authorizations
- Responds to queries from subsidiaries , manufacturing plants and other departments within the company
- Has obtained a (Industrial) Pharmacist degree , Ph.D. or Master degree in a scientific discipline (most of these candidates have a lot of knowledge of medicines) with a first experience in an production environment
- Has an excellent knowledge of English and Dutch
- Is very interested in the Pharmaceutical Industry
- Is able to work autonomously and to set priorities
- Is accurate, critical and flexible
- Has a high sense of responsibility
- Is well organized (respecting strict timings)
- Has a good eye for detail
- The candidate can be a school graduate, but has to be motivated and willing to learn (right attitude!).
- Candidates with a few years of experience as a pharmacist, but who are looking for another kind of function within pharma, can be interesting too.
- Experience is not mandatory! Training on the job.
- A strong interest: lifecycle of medicines & the pharmaceutical industry.
What we offer
You will receive a competitive based salary depending on your education and experience in an attractive package of extralegal benefits (company car, petrol card, meal vouchers, group insurance, hospitalization…). Each employee will be welcomed with a varied integration program. We invest considerable time and resources in training our staff (technical and non-technical courses). You will join a dynamic and international environment with enthusiastic and professional colleagues.
Who we are
Keyrus Biopharma is an international Consulting, Contract Research Organisation and Functional Services provider with a reputation for transparency and integrity, highly focused on being able to deliver with excellence. Our ‘human’ approach to service provision is what differentiates us from our competitors. Combined with our high caliber staff, this approach has allowed us to become a key player in clinical research.
At Keyrus Biopharma we’re proud of our commitment to delivering services of the highest quality, not only skillfully, efficiently and reliably, but also with sincerity and genuine care for our clients’ projects, priorities and reputation. Thus we maintain and advance our vision and our standards, all the while ensuring that we serve your interests better
From early- to late-stage drug development, our range of services includes: Project Management, Clinical Operations, Pharmacovigilance, Quality Assurance (GxP), Regulatory Affairs Strategy & Support, Data Management, Medical Review & Coding, Biostatistics, Medical Writing & Medical Information, Real World evidence services.
Keyrus Belgium Offices:
- Chée de Louvain 88 - Waterloo-Lasne
- Rue Emile Francqui, 1 - Mont-Saint-Guibert
- Nijverheidslaan 3, - Strombeeck Bever