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Regulatory Affairs Specialist

1 semana atrás

Lisboa, Lisboa, Portugal Randstad II - Prestação de Serviços, Limitada Tempo inteiro

Our client is a chemical group, with activities in several markets worldwide, that want to strengthen their Regulatory Affairs Department. This team is responsible for preparing and submitting biocide and medical device registration dossiers meeting requirements according to BPR and MDR.

Responsabilidades Chave

  • As a member of the registration team having the joint responsibility for maintaining company' continued compliance with European regional and national chemicals legislation.
  • Responsible for preparation and submission of registration dossiers in the framework of the Biocidal Products Regulation, supporting both national authorizations (pre-BPR) as well as obtaining approvals to BPR.
  • Interact with external services providers (consultants and laboratories) for the generation of physical-chemical and efficacy tests, toxicological tests and risk assessments.
  • Interact with authorities on existing and future submissions.
  • Interact with internal stakeholders (Regulatory, R&D, Portfolio Management, Application Management) providing input to the registration dossiers. Drive decision making by proposing registration strategies, maintaining adherence to deadlines and providing expert knowledge of what is feasible.
  • Provide guidance on registration requirements to R&D during new product developments.
  • Maintain informed about developments in national and European (biocide) regulation. Assess the potential impact to the company and alert internal stakeholders.
  • Participate in advocacy (e.g. via trade associations) in an effort to influence regulatory developments in order to minimize impact.

Competências

  • A University Degree in Scientific background: Master or PhD, in Chemistry, Biochemistry, Toxicology, or Ecotoxicology.
  • 3 to 5 years of industry experience within Regulatory Affairs (registration, development, maintenance).
  • Experienced in Chemical Legislation, Chemical industry, Chemical Regulations (i.e. BPR, CLP, REACH, PPPR) & preparing regulatory dossiers.
  • Proficiency in spoken and written English; knowledge of any other languages would be an asset.
  • Project management skills, follow-through, and hands-on approach.
  • Attention to detail and meeting deadlines.
  • Analytical mind.

Principais Benefícios

An excellent remuneration package, in line with the responsibility of this position.

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