REGULATORY AFFAIRS

BrusselIIndustrie pharmaceutique

Description de fonction

For one of our pharma clients in Brussels we're looking for a REGULATORY AFFAIRS LIAISON.

Your tasks consist of:

  • Responsible for coordinating the preparation, review and submission of regulatory dossiers in support of new drug applications, and post-approval submissions in the EEA, Switzerland and non-EU CES countries
  • For assigned development and/or marketed products, lead cross-functional Teams as appropriate
  • Work with project teams and department management to develop and implement regulatory strategies (including scientific advices and paediatric investigational plans, or orphan designation), identify regulatory risks, and enable earliest possible approval. Ensure regulatory strategies are aligned with project teams and business objectives and deliverables.
  • Serve as principal regulatory contact with regulatory agencies and HQ affiliates
  • Serve as the Regulatory Affairs representative on assigned non-product related cross-functional teams. Develop and implement effective processes to meet business objectives and ensure appropriate compliance with regulatory requirements
  • Communicate new regulations and standards which may affect the products to other regional colleagues to ensure any broader impact to the organization is also fully understood
  • Educate, train, and advise company professionals to ensure appropriate compliance with internal and external processes and procedures
  • Maintain a thorough knowledge of specific diseases within therapeutic areas assigned; including a detailed understanding of the prevailing attitudes and the practices in each country toward those diseases and their treatment
  • Attend appropriate outside meetings and courses to maintain competency and awareness in his/her product area, international regulatory activities, and the pharmaceutical industry at large
Profil

As REGULATORY AFFAIRS LIAISON your profile matches the following description:

  • You have a medical degree, or a PhD or master in life sciences
  • You have 5 years' experience in the pharmaceutical sector
  • You are fluent in English (both written and spoken)
  • You have demonstrated competence in biomedical research gained through appropriate experience of 3-4 years and possess an excellent working knowledge of Regulatory Affairs or Clinical Research gained within industry would be considered
  • You possess outstanding, interpersonal, written and oral communication skills
  • You are able to work both reactively and proactively in a timely manner in a dynamic fast-paced environment
  • You have knowledge/experience of EU regulations, guidelines and regulatory processes for products in development and in life-cycle maintenance
  • You can adhere to strict project timelines
Descriptif de l’organisation et du département

Select Projects is part of the Select group, a collection of HR companies that put people first because Quality is Performance by Genuine People. Select Projects provides technical support to clients on a project basis. Our 220 employees in Belgium and the Netherlands support companies with their projects in various domains: Life Sciences, (petro) chemical, Construction and Rail. From our offices in Antwerp and Rotterdam we optimally support our experienced specialists so that they can deliver high quality to our customers at all times.

Offre

You get an attractive salary package with interesting fringe benefits. A company car, meal vouchers, group insurance and mobile phone subscription are possible. We ensure that you end up in a pleasant working environment with nice colleagues and opportunities to develop and further develop. Together with you, we map out a training course tailored to your future plans and needs.

Avez-vous des questions?
Julie Tilborghs Consultant Select Projects +32 3 203 50 85
REGULATORY AFFAIRS Informations offres d'emploi
68232
Ingénierie - Projets
Project Sourcing
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