Regulatory Affairs Trainee

16 hours ago

Bucharest, Bucureşti, Romania Sales Consulting Full time 20,000 - 25,000 per year

Responsabilities:

  • Support the preparation of regulatory applications to enable new products to be launched and maintained in market, with the correct alignment and compliance to internal and external regulations;
  • Manage compliance within defined activity streams in line with company expectations - support key compliance processes and ways of working (e.g., in relation to company global regulatory teams, quality, product labeling requirements, websites safety standards, as well as local MoH regulations);
  • Maintain up-to-date required regulatory compliance databases, systems and processes, such as planned submission date/ actual submission date / approval date;
  • Support the regulatory team with the preparation of necessary documents required for submission and approval of cosmetic products in Republic of Moldova;
  • Maintain Regulatory Documents archive and local trackers;
  • Support the regulatory team in review and preparation of regulatory applications related to promotional campaigns;
  • Support the regulatory team in review and approval of products artworks;
  • Support the regulatory team in review the correctness of approvals obtained from authorities;
  • Perform administrative activities including but not limited to scanning, filing, and archiving regulatory documents;
  • Maintain high level of knowledge on legislation for company products portfolio.

Qualifications: 

  • Fluent written and verbal communication in English;
  • Ability to effectively communicate and negotiate in relation to technical information and regulations is key;
  • Planning and organization skills;
  • Proactive;
  • Attention to details;
  • Excellent interpersonal, time management, organizational and communication skills.

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