Senior Regulatory Affairs Officer

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