Senior Regulatory Affairs Officer (NL)

10-11-2021
Netherlands Barneveld or Belgium Bornem
32 - 40 uur

The Pelsis Group is looking for a Senior Regulatory Affairs Officer

Purpose

  • Defend existing registrations and registering new products (biocidal products and plant protection) at EU level and country level.
  • Support the continuous improvement of projects related to Regulatory Affairs procedures, processes, standard and systems to ensure the regulatory compliance of the chemical product portfolio.
  • Act as a source of information to other team members

Key Accountabilities

  • To coordinate, prepare and following up on country and EU biocidal registration projects within agreed costs and timelines
  • Strategic advice, data gap analysis, product development and task force/consortia management.
  • Dossier writing including review of (biologic, toxicologic) study plans and reports to ensure that regulatory and scientific requirements are achieved
  • To engage in interactions with regulatory authorities and relevant industry bodies at EU and country level
  • To advise and support our local Teams in compliance with legal requirements.
  • To support to NPD activities through discussion and responses to new project briefs.

Reports to

Regulatory Affairs manager, Head of Regulatory Affairs  

Job Role Attitude

  • Have a positive and optimistic attitude
  • Problem solver who can find pragmatic solutions to technical challenges
  • Excellent teamwork skills

Experience, Skills and Qualifications

Qualifications

  • Suitable candidates will have a scientific background (chemistry or biology) along with an understanding of regulatory / registration processes and requirements.
  • You live in Belgium (Bornem area) or the Netherlands (Barneveld area).

Experiences

  • No less than 3 – 4 years of regulatory experience with PPPR, BPR and/or veterinary products is required.
  • Hands-on experience with toxicological or eco-toxicological risk evaluations
  • Know-how of ECHA IT tools such as IUCLID and R4BP (pre)

Skills

  • Excellent communication skills in English and preferably in one or more other EU languages (verbally and in written)
  • Ability to consolidate large volumes of complex information, interpret & construct straightforward plans
  • Attention to details
  • Project orientated with strong time-management skills (experience with NPD and stage gate process)
  • Ability to work well under pressure both independently and as part of the team

Interested? Then I would like to receive your motivation and CV by e-mail monique.vanbart@pelsis.com