For one of our clients located in Sint-Lambrechts-Woluwé, we are currently looking for a "Support in regulatory affairs at country level".
Under supervision of the Regulatory Affairs Country Lead, the contractor is responsible for providing regulatory administrative support and coordination for the department with maintenance of tracking systems and databases, minor translations, preparing submissions, renewals and PSURs and maintenance of local files as well as minor translations and artwork management.
- The region that would fall under the contractors responsibilities - is limited to Belgium and Luxembourg.
- Assists in compilation and submission of regulatory documents to the local regulatory authorities and - as applicable - to the European Medicines Agency (EMA) related to new applications, variations, renewals, PSURs etc.
- Builds and maintains standard Regulatory Official Files as well as Marketing Authorization filing and approval binders according to local SOPs.
- Ensures that regulatory databases and systems are kept updated and complete.
- Participates in establishing and maintaining of relevant Standard Operating Procedures to secure that the current regulations are complied with.
- Participates in implementation of updated regulatory documentation according to Agency requirements and in-house guidance.
- Manages the planning and submission activities for PSURs, in cooperation with regional and global teams.
- In connection with submission of MA applications, variations, renewals and PSURs etc assists in preparation, translation and QRD check of Summary of Product Characteristics and Patient Package Leaflets and performs quality assurance including linguistic check of these documents.
- Coordinate Electronic Medicines Compendium submissions, approvals and record keeping.
- Ensures that artwork including all package components (leaflets, labels, outer cartons etc), is developed in a timely and correct manner and according to relevant Artwork Management procedures.
- Packaging Material is developed in cooperation with the MMD, RAE coordinators, the Product Manager, and (Sr) Manager Regulatory Affairs.
- The contractor proof reads packaging components and is responsible for maintaining an updated file on packaging components, as applicable.
Do the above responsibilities fit you like a glove?
Download your CV and motivation letter via the "apply now" button and you can expect feedback from us soon.
If something is not entirely clear, you can reach out to us by telephone off course.
- Degree in: Pharmacist or equivalent
- Language: Dutch /French/English + (optional) German reading
- Experience : min 2 years RA local
- Dealing with most aspects of registration, with sufficient working knowledge of the subject area to require minimal supervision from the Manager.
- A sound appreciation of the interactions and relationships of the dept with other groups internally is expected.
- Computer skills: word-processing, spreadsheets, database applications, and internet.
- This is a long term consultancy project for min 1 year ( Possibility of extension with 2 years )
- This is a position for min 32 hours and max 40 hours.
- Home working is allowed with a max of 2 days/week
- A balanced salary package based on your capabilities and experience, including a mobile phone, meal vouchers, ...
Existing right to work in Europe required ( please read job spec in full before applying ).
Vacancy number: 16122