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Head of Regulatory Affairs

Vacaturenummer: A2000191
Denka International - Barneveld (Nederland)

For our client, Denka International, we are looking for a Head of Regulatory Affairs.


Profile
Are you that talented people manager with excellent interpersonal skills who can guide and train the (regulatory) team members? We are looking for a candidate with a positive and optimistic attitude who likes to work together with his team to get the job done!
You will lead and coach the regulatory team, current 3 FTE (by 2022: 6 FTE). You ensure personal development plans are in place. Support members of the Regulatory Team with their projects including REACH, UFI codes, ePIC, local regulatory issues, CLP/SDS.
You lead and co-ordinate various major regulatory projects (e.g., active substance dossiers). Ensure that project team is delivering according objectives and report project progress in-line to the stage gate requirements.
You are responsible to deliver new IP and maintain current registrations and lead continuous improvement project related to Regulatory Affairs procedures, processes, standard and systems, to ensure the regulatory and REACH compliance of the chemical product portfolio.
You keep track on regulatory and guidance changes and identify consequences and mitigations to the various problems.
Accountabilities:
  • Successfully develop the regulatory dossiers concerning certain biocidal and/or plant protection product dossiers and active substances dossiers to several EU authorities within agreed costs and timelines. These dossiers serve as basis for the local/country registrations;
  • Prepare annual regulatory maintenance program to keep existing registrations alive (national renewals);
  • Actively follow the EU biocidal and plant protection regulations and proactively prepare and/or co-ordinate actions to mitigate products that (will) become at risk;
  • Support NPD activities through discussion and responses to new project briefs to ensure marketing requirements are timely reviewed.


Who we're looking for
The ideal candidate has a master/Ph.D. degree, preferably in chemistry or biology, along with in-depth understanding of regulatory / registration processes and requirements. You live in the Netherlands and you are willing to travel occasionally.
You have at least 10 years of regulatory experience with PPPR, BPR and/or veterinary products. Thorough knowledge of the ins and outs of the Dutch and EU regulation and procedures. You like to participate in working groups (e.g., Nefyto) or EU industry associates (e.g., EU biocidal product forum). We are looking for someone who is not afraid of expressing their opinion and standing for their decisions. Are you the pro-active RA Head with understanding of the business we are looking for?


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
Reference:A2000191
Contract:Direct contract with client
Education:WO/MSc. PhD.
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

CLS Services is a leading professional recruitment agency, specialised in the recruitment and career coaching of people with a background in chemistry & life sciences.