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JR. REGULATORY AFFAIRS OFFICER, Location: Bucharest

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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