Regulatory Affairs Specialist Lisboa

Regulatory Affairs Specialist
Lisboa
Lisboa, Lisboa, Portugal

Christeyns is a privately owned detergents and chemicals group, with activities in several markets worldwide, completely focused on a B-2-B environment.  Our head office is located in Ghent, Belgium. The Group employs about 1100 people across 30 countries. Over the last 15 years, Christeyns has enjoyed rapid growth of around 15% per year and now has a consolidated turnover of around 400 million Euro.

Christeyns stands for premium detergents and disinfectants, reliable equipment, and flexible customised services. Our portfolio includes hygiene solutions for professional textile care, food processing & retail, the professional cleaning industry, and the medical and life sciences sectors.   

Rapid company growth and an increasingly challenging regulatory environment in Europe raises the need to strengthen our Regulatory Affairs Department. Christeyns Portugal-based Corporate Registration team is responsible for preparing and submitting biocide and medical device registration dossiers meeting requirements according to BPR and MDR.

Key Responsibilities:

• As a member of the registration team having the joint responsibility for maintaining Christeyns’ 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
  - 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 Christeyns and alert internal stakeholders.
• Participate in advocacy (e. g. via trade associations) in an effort to influence regulatory developments in order to minimize impact to Christeyns.

Qualifications:

• A University Degree in Scientific background: Master or Ph
  D, in Chemistry, Biochemistry, Toxicology. Ecotoxicology.
• 3 to 5 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,
  - through and hands on approach.
• Attention to detail and meeting deadlines.
• Analytical mind.

Personal Attributes

• A strong team player, with the ability to work effectively in a team setting and interact with people of different cultural, seniority and functional backgrounds.
• Highly
  - motivated and able to drive activities.
• Excellent communication skills.
• Responsibility, autonomy, and resilience.

We offer you :

• A strong, stable and growing company with a highly respected position in the market.
• A strategic role, enabling you to be part of the future growth and success of the company.
• An excellent remuneration package, in line with the responsibility of this position.