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Senior Regulatory Affairs Officer

Regulatory Affairs PPPR BPR toxicology eco-toxicology risk evaluation

Job

CLS Services is a leading professional recruitment agency specialised in chemistry & life sciences.
For our client Denka International we are searching for a Senior Regulatory Affairs Officer.

Keywords
  • M.Sc./Ph.D.
  • Regulatory Affairs
  • PPPR, BPR and/or veterinary products
  • Toxicological or eco-toxicological risk evaluations

Are you that problem solver who can find pragmatic solutions to technical challenges?
As Senior RA Officer, you will defend existing registrations and register new products (plant protection and biocidal products) at EU level and country level. You 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.

Key Accountabilities:
  • Co-ordinate, prepare and follow 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 the local teams in compliance with legal requirements;
  • To support to NPD activities through discussion and responses to new project briefs.

Profile

The ideal candidate has a scientific background, Ph.D. or M.Sc. in chemistry or biology, with 3-4 years of regulatory experience with PPPR, BPR and/or veterinary products. You have hands-on experience with toxicological or eco-toxicological risk evaluations and you have knowledge of ECHA IT tools such as IUCLID and R4BP (nice to have).
We are looking for someone with the following 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.

Benefits

Salary: max 73.000 gross/year
Days of leave: 36
See here our other employment terms for this vacancy

Company profile

Since 1932 Denka International is directional in registrating, formulating and producing biocides, plant protection products and veterinary medicines. At Denka International the protection of the environment, people and animals is stated. Denka International is authorised for preparation, packaging, labelling and register of veterinary medicines under GMP regime.

Contact

Interested? Send us (CLS Services) a detailed curriculum vitae, accompanied by an application letter indicating your motivation. Please use our online application form.
Location Barneveld
Senior Regulatory Affairs Officer

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