REGULATORY AFFAIRS TRAINEE; Location: Bucharest, Hibrid

Sales Consulting activates on the HR market since 1998, having a national coverage in several areas of expertise: recruiting and selection assessment center HR market mapping/due diligence projects, personnel leasing, payroll.

Sales Consulting has 2 fully operational branches: Cluj-Napoca (also the head-office) and Bucharest.
We are developing various projects (Recruitment, Training and Consultancy) in some of the most varied type of industries:
- AUTOMOTIVE/PRODUCTION/ENGINEERING (Specialists and Middle & Top Management positions)
- OUTSOURCING (BPO/SSC/CC)
- IT & C (C++, C#, .NET, Java, Linux etc)
- FMCG (sales & purchasing positions; all levels)
- PHARMA (all levels)

- Review products artworks;
- Review advertising and promotional materials;
- Review approvals obtained from authorities;
- Support in the maintenance of globally required regulatory databases and local trackers;
- Preparation and submission of regulatory variations and new Marketing Authorization Applications;
- Preparation of advertising and promotional materials applications submissions;
- Administrative activities including but not limited to scanning, filing, and archiving regulatory documents.
- Bachelor`s degree qualification in Life science/Pharmaceutically related science (Chemistry, Pharmacy, Biochemistry, Biology, Medical Engineering);
- Precise in work, proactivity, reliability, good team player, focus on details, meeting deadlines and enable to cope with complex tasks, ability to multi-task and work under pressure;
- Intermediate level of English, both written and spoken is a must!

- Manage 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 portfolio/activity streams in line with company expections - support key processes and ways of working (eg, in relation to company global regulatory teams, quality, product labeling requirements as well as local MoH regulations);
- Maintain required regulatory compliance databases, systems and processes;
- Maintain Regulatory Documents archive;
- Support the regulatory team in review and preparation of regulatory applications including advertising and promotional materials submissions;
- Support the regulatory team in review and approval of products artworks;
- Maintain high level of knowledge on legislation for company products portfolio.

Only eligible candidates will be contacted. Thank you for your interest!