Senior Regulatory Affairs Officer
Denka International - Barneveld (Nederland)
For our client, Denka International, we are looking for a Senior Regulatory Affairs Officer .
Are you that problem solver who can find pragmatic solutions to technical challenges?
You will defend existing registrations and registering 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 and REACH compliance of the chemical product portfolio.
- Co-ordinate, 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.
Who we're looking for
We are looking for a candidate with a scientific background, Ph.D. or M.Sc. in relevant study like chemistry or biology. Further you have several years experience in regulatory and registration processes and requirements.
- At least 3 – 4 years of regulatory experience with PPPR, BPR and (preferably) veterinary products;
- Able to consolidate large volumes of complex information, interpret & construct straightforward plans;
- Know-how of ECHA IT tools such as IUCLID and R4BP;
- Know-how of toxicological and eco-toxicological risks (pre).
- Attention to details;
- Project orientated with strong time-management skills (experience with NPD and stage gate process);
- Able to work well under pressure both independently and as part of the team;
- You have excellent communication skills in English and preferably in one or more other EU language.
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|
|Employment terms||:||Salary: 50.000-65.000|
Days of leave: 24 + 12
See here our other employment terms for this vacancy
|Location||:||View location with Google Maps|
|+31 (0)88 22 77 555|
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