Regulatory Affairs Associate

Région
Gent
Publication
mardi 18 avril 2017
Date limite
jeudi 18 mai 2017
Réf
72DFEXPE-BE
Contact
Astrid Kinoo
Fonction
Autre
Niveau d'expérience
0 à 2 ans d'expérience
Type de contrat
Fixe
Temps de travail
Temps plein
eXPErt services for eXPErt professionals.
That's XPE. For one of our clients we are looking for: Regulatory Affairs Associate Organisation description:

Our client, a global company providing high-quality healthcare pharmaceuticals and nutritionals, is hiring a dynamic Regulatory Associate. Initially for a period of 6 months, but with the opportunity to be engaged on permanent base. The company is open for juniors as long as you can start rapidly. This role is in place to support the commercialization of the company's diverse portfolio in export markets (mainly non-EU markets where the company operates via distributors) and support 3rd party contract business within and outside Europe. As a Regulatory Associate, you will focus on working with a complex network of stakeholders, to achieve registration and life cycle maintenance and compliance. You are an integral part of the International Contract and Export (ICE) Regulatory Affairs Team.

Job description:

By liaising and working closely with both local distribution partners and internal cross-functional teams, you will ensure: STRATEGY SUPPORT Understand market specific needs and requirements in order to assist in developing innovative regulatory strategies. STRATEGY IMPLEMENTATION Preparation and submission of new registration, renewal and variation packages and support replying to RA questions raised by local Health Authorities. Validate packaging materials. Keep the internal Regulatory Affairs databases and trackers up-to-date. Provide regulatory support for the 3rd party contract business. STAKEHOLDER MANAGEMENT External and internal stakeholders around the world.

Profile:

You have a higher degree in life sciences and a first experience in regulatory affairs within the pharmaceutical industry. Ideally, you have hands on experience with biocide, cosmetics and food supplements, if a minimum of basic understanding of biocide, cosmetics and food supplements regulatory affairs is required. Your analytical skills enable you to appraise information and easily identify the gaps / issues. ‘Can Do' is your motto. As of day one, you will dive in and get the job done. Strong, clear and concise communication is key for working across cultures / countries. English and Dutch hold no secrets from you and you can effectively and fluently communicate in both languages.

Offer:

You are offered a full time 6 months contract with the possibility after to be engaged permanently by the client. You gain experience in a global, fast growing business and within a collaborative and entrepreneurial working environment where employees can be proud of the meaningful work they do!



Licenses
XPE Personnel Services NV/SA: Flanders: VG15/BU, Brussels: B-AA5.031, Wallonia: W.RS.002/W.INT.002
XPE Group NV/SA : Flanders: VG1834/B, Brussels: B-AA11.007, Wallonia: W.RS.713