Senior Regulatory Affairs Lisboa

Senior Regulatory Affairs
Lisboa
Lisboa, Lisboa, Portugal

Our client is a chemical group, with activities in several markets worldwide, that wants 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.

As a member of the registration team, you will have the joint responsibility for maintaining the company's continued compliance with European regional and national chemicals legislation.

Your responsibilities include:

1. Preparation and submission of registration dossiers under the Biocidal Products Regulation, supporting both national (pre-BPR) and BPR approvals.
2. Interacting with external service providers (consultants and laboratories) for chemical, efficacy, toxicological tests, and risk assessments.
3. Communicating with authorities regarding existing and future submissions.
4. Collaborating with internal stakeholders (Regulatory, R&D, Portfolio Management, Application Management) to provide input for registration dossiers, propose registration strategies, meet deadlines, and offer expert insights.
5. Guiding R&D on registration requirements during new product development.
6. Staying informed about developments in national and European biocide regulation, assessing impacts, and alerting stakeholders.
7. Participating in advocacy efforts (e. g. , via trade associations) to influence regulatory developments and minimize impact.

Qualifications include:

• A university degree in a scientific field: Master’s or Ph
  D in Chemistry, Biochemistry, Toxicology, or Ecotoxicology.
• 3 to 5 years of industry experience in Regulatory Affairs (registration, development, maintenance).
• Experience with chemical legislation, chemical industry regulations (BPR, CLP, REACH, PPPR), and preparing regulatory dossiers.
• Proficiency in spoken and written English; knowledge of additional languages is an asset.
• Strong project management skills with a
  - on approach.
• Attention to detail, ability to meet deadlines, and an analytical mindset.

Benefits include:

An excellent remuneration package commensurate with the responsibilities of the position.