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Senior Regulatory Affairs Officer

Vacaturenummer: A2000190
Denka International - Barneveld (Nederland)

For our client, Denka International, we are looking for a Senior Regulatory Affairs Officer.

Are you the new Senior Regulatory Affairs Officer who will defend existing registrations and registers new products (plant protection and biocidal products) for Denka?

You will co-ordinate, 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. Additionally, you will review (biologic, toxicologic) study plans and reports, to ensure that regulatory and scientific requirements are achieved.
As Senior RA Officer, you will review product labels to make sure they comply to all the different regulations. You 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.

  • Engage in interactions with regulatory authorities and relevant industry bodies;
  • Advise and support local Teams in compliance with legal requirements;
  • Support NPD activities through discussion and responses to new project briefs.

Who we're looking for
The ideal candidate has 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 occasionally. You require at least 3 – 4 years of regulatory experience with PPPR, BPR and (preferably) veterinary products.
  • Know-how of ECHA IT tools such as IUCLID and R4BP;
  • Know-how of toxicological and eco-toxicological risks (pre);
  • Experience in product development (e.g., biological performance assessments are a pre);
  • Excellent communication skills in both Dutch and English (verbally and written);
  • Project orientated with strong time-management skills (experience with NPD and stage gate process).

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.

Additional vacancy information
Contract:Direct contract with client
Education:HBO/BSc. WO/MSc.
Employment terms:Days of leave: 24+12
Publication date:21-12-2020
Location:View location with Google Maps
Contactperson:René Kemps
+31 (0)88 22 77 555

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