Regulatory Affairs Junior
Regulatory Affairs Junior
Blauwesteenstraat 87, Kontich, Belgium
Flen Health is an international family owned company with ambitious growth plans in the pharmaceutical and medical device technological domain. Flen Health has a range of products for wound and skin care, several new products in the pipeline and research cooperation agreements in Europe and the USA.
At Flen Health, we are convinced that we do help people live the life they love through developing innovative technologies and bringing these to patients across the globe. We focus on patients with topical inflammatory and infectious diseases.
At Flen Health, we expect you to show grit, to take ownership of your initiatives, to go for it and we guarantee that you will then appreciate the result of your work, whether individually, as a team or company-wide as Flen Health. As an intrapreneur, you will enjoy working in a multicultural diverse environment where trust and open communication are key, and where a positive can do attitude drives sustainable growth. We offer a flexible working eco-system, enthusiastic colleagues, and an attractive remuneration package.
We are looking for a Regulatory Affairs Junior to support the Regulatory Affairs Department concerning the registration and the maintaining of all Flen Health products in the countries where Flen Health commercializes its products in order to cope with the ISO standards and other regulations. The Regulatory Affairs Junior will advise on legal and scientific restraints and requirements which means collecting, collating and evaluating scientific data. This full-time and permanent position will be located in Belgium or in Luxembourg.
What we offer:
Excellent working conditions
An innovative and inspiring work environment
Independent project work & responsibilities within a professional team
Learning and development opportunities
Competitive remuneration according to experience
Support the Regulatory Affairs’ department in preparing product technical dossiers and other regulatory documents for registration submissions in and outside EU.
Support the Regulatory Affairs’ department in keeping product technical dossiers and other regulatory documents up to date during the lifecycle of Flen’s products
Help to be compliant and to maintain the CE and ISO certificate requirements
Participate in the implementation of the new Medical Device Regulation within Flen
Support the regulatory compliance of communication activities and materials (brochure, presentation, packaging material etc.) regarding Flen’s products, in close collaboration with marketing and sales
Attend relevant courses (internal and external) to further expand current knowledge of regulatory affairs related to EU or FDA and or non-EU regulations and willing to keep your knowledge updated by self-education/ training
Keep abreast of international legislation, guidelines and customer practices by keeping in contact with official institutions
Identify evolving regulatory trends including international trends that are relevant and ensure that appropriate action is initiated
Work in close collaboration with Regulatory Affairs team
Your qualifications & experience:
Master’s degree in Industrial Pharmacy/Pharmaceutical Sciences or related scientific Master
First Professional experience in international regulatory affairs is added value.
Willing to acquire knowledge of regulatory affairs related to EU or FDA or other non-EU regulations
Ability to read and understand competent authority regulations, guidance documents, test reports and technical/chemical product information
Strong time and project management skills/knowledge is an asset
Proficient with all Microsoft Office applications (Word, Excel, PowerPoint, Project, etc.), experience in Data capturing tools is a plus
Self-motivated team worker
Share recommendations, experiences and best practice with colleagues
Creating enthusiasm and initiative to make things happen
Listening to others and giving constructive feedback
Fluency in English, both written and spoken, another language is an asset.
Are you interested in working with an ambitious and very dedicated team?
Please send your application, CV and covering letter to the following email address: email@example.com