JR. REGULATORY AFFAIRS OFFICER, Location: Bucharest

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Employer: SalesConsulting
Domain:
  • Pharmacy - Health
  • Job type: full-time
    Job level: 1 - 5 years of experience
    Location:
  • BUCHAREST
  • nationwide
    Updated at: 02.10.2019
    Remote work: On-site
    Short company description

    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)

    Requirements

     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.

    Responsibilities

     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

    Other info

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

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