JR. REGULATORY AFFAIRS OFFICER, Location: Bucharest
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Employer: | SalesConsulting |
Domain: |
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Job type: | full-time |
Job level: | 1 - 5 years of experience |
Location: |
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Updated at: | 02.10.2019 |
Remote work: | On-site |
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)
University education Pharmacy, Medicine, Chemistry, Biochemistry, Biology;
Minimum 6 months-1 year experience in Regulatory Affairs or related departments in pharma
Strong communication skills;
Analytical thinking and attention to details;
High level of organizational skills and prioritizing;
Pro-active, positive and can-do attitude;
Problem-solving skills;
Good team player works well in cross-functional teams;
English - advanced level.
Manage preparation and submission of new regulatory documents, dossiers and applications to enable new products to be launched and maintained in market;
Manage preparation and submissions of the CMClabelling variations, MAH transfer dossiers with the correct alignment and compliance to regulations;
Maintains updated prescribing information in artwork packaging in line with the latest approved registration details;
Ensure products are maintained and meet internal and external compliance requirements;
Be a productive part of defined local regulatory team, including being a proactive partner to other stakeholders, eg, marketing and sales within local commercial business, supply chain and quality etc.;
Work together with regulatory colleagues and other stakeholders to proactively look for opportunities and solutions to challenges;
Maintain required regulatory compliance databases, systems, and processes;
Administrative tasks
Only the eligible candidates will be contacted. Thank you for your interest!
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