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R&D Regulatory Affairs Trainee

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Vale de Cambra, Portugal

We are looking for a Regulatory Affairs Trainee to join our R&D team and to collaborate in the organisation and management of the regulations and other regulatory topics under our R&D portfolio.

Main Activities and Responsibilities:

  • Collaborate with the Regulatory Affairs Coordinator in the organization and management of the applicable regulations under R&D portfolio and other regulatory topics of interest including some specific legal requests;
  • Support the team to ensure that the formulations and finished products comply with applicable regulatory requirements;
  • Support on the preparation of guidance in some relevant regulations such as aerosols dispensers, biocides, cosmetic products, medical devices, medicinal products;
  • Support in the organization and management of the information received from the suppliers for applicable to all Raw Materials used by R&D;
  • Support on the management and organization of all tasks related to ‘Claim Substantiation Tests’;
  • Support on the final assessment of the criteria used by PD teams to comply with some of the mandatory cosmetic products regulatory requirements such as: PAO, Expire Date, Microbiological Low Risk Products amongst others;
  • Support on the regulatory assessment for the claims, determination of substantiation plan (scope of study, protocol approval, data and report analysis);
  • Support on the verification of Products Dossiers; Stability Reports; Product Information Files (PIFs);
  • Support on the preparation and verification of final product products Artwork Labelling.

We are looking for:

  • Degree in Pharmacy, Chemistry, Chemical Engineering, Biochemistry, Biology or similar;
  • Experience and knowledge in cosmetic products and other applicable product regulations will be valued, as well as basic knowledge in medical devices and medicinal products;
  • Proficiency in Microsoft Office tools: Excel, PowerPoint, and Word;
  • English language qualification or high experience level;
  • Curious and proactive profile with good ability to learn;
  • Good communication skills – verbal and written;
  • Focused on goals, organised and meticulous;
  • Good planning and organisational skills;
  • Teamwork capabilities.

What we offer:

  • Integration in an international and multicultural company with real opportunities for career development;
  • Unique and challenging projects with global impact;
  • Positive, informal and energetic work environment;
  • Plenty of space for curiosity, creativity and growth;
  • Interesting Portfolio of Products;
  • Health Service for employees and Employee Assistance Programme, with support in Psychological, Legal, Financial and Work-Life / Social areas.

How to apply? 

Send us your application and CV by 31/03/2022, to Recursoshumanos.cp@colep-cp.com with “Regulatory Affairs Trainee” as subject.