JOB DESCRIPTION

Company

Denka International – Pelsis Group

Country

The Netherlands

Job Title

Senior Regulatory Affairs Officer

Reports to

Head of Regulatory Affairs

Purpose

  • Defend existing registrations and registering new products (plant protection and biocidal products)
  • Review product labels to make sure they comply with all the different regulations.
  • Support continuous improvement project related to Regulatory Affairs procedures, processes, standard and systems to ensure the regulatory and REACH compliance of the chemical product portfolio.

Main responsibilities

  • To coordinate, prepare and follow domestic and international biocidal registration projects within agreed costs and timelines
  • including strategic advice, data gap analysis, biocidal product family development/construction and task force/consortia management.
  • 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
  • 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.

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 the Netherlands and you are willing to travel sometime.

Experiences

  • No less than 3 – 4 years of regulatory experience with PPPR, BPR and (preferably) veterinary products is required.
  • Know-how of ECHA IT tools such as IUCLID and R4BP
  • Know-how of toxicological and eco-toxicological risks (pre)
  • Experiences in product development (e.g. biological performance assessments is a pre)

Skills

  • Excellent communication skills in both Dutch and English (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

If you have more questions, or want to apply for this role send your resume to Monique.vanBartHemmes@pelsis.com

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