Senior Regulatory Affairs Oeiras

Senior Regulatory Affairs
Oeiras
Oeiras, Lisboa, Portugal

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

Key Responsibilities

• Maintain the company's compliance with European chemicals legislation as part of the registration team.
• Prepare and submit registration dossiers under the Biocidal Products Regulation, supporting national authorizations (pre-BPR) and BPR approvals.
• Coordinate with external service providers (consultants and laboratories) for
  - chemical, efficacy, toxicological tests, and risk assessments.
• Engage with authorities regarding current and future submissions.
• Collaborate with internal teams (Regulatory, R&D, Portfolio Management, Application Management) to develop registration strategies, ensure deadlines are met, and provide expert advice on feasibility.
• Guide R&D on registration requirements during new product development.
• Stay informed about updates in national and European biocide regulations, assess impacts, and alert stakeholders. Participate in advocacy efforts through trade associations to influence regulatory developments and minimize negative impacts.

Qualifications

• 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, including registration, development, and maintenance.
• Experience with chemical legislation, industry standards, and preparing regulatory dossiers (e. g. , BPR, CLP, REACH, PPPR).
• Proficiency in spoken and written English; additional languages are a plus.
• Strong project management skills, proactive, with a
  - on approach.
• Attention to detail and ability to meet deadlines.
• Analytical mindset.

Main Benefits

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