Regulatory Affairs Trainee
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Job Location:
Monthly Salary:
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
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.
Key Skills
- Proofreading
- Adobe Acrobat
- FDA Regulations
- Manufacturing & Controls
- Biotechnology
- Clinical Trials
- Research & Development
- GLP
- cGMP
- Product Development
- Chemistry
- Writing Skills
About Company
Since 1998 weve been active in the Human Resources consulting market providing regional coverage across four key areas of expertise: recruitment and selection personnel leasing assessment centers and consultancy. As leaders in Transylvania weve expanded our reach to embrace a culture ... View more
