Regulatory Affairs Trainee | Medical area

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Employer: Reckitt Benckiser
Domain:
  • Quality Control
  • Pharmacy - Health
  • Job type: full-time
    Job level: 0 - 1 years of experience
    Location:
  • BUCHAREST
  • Updated at: 12.04.2017
    Remote work: On-site





    Who we are

    We’re 37,000 entrepreneurs, all inspired by a vision of a world where people are healthier and live better. At the heart of our rapidly growing consumer health business is a passionate desire to help people feel better. We invest in research and development to find new ways for people to look after themselves, their families and home.

    Why join RB?

    1. You are trusted. You are given the full accountability and autonomy from day 1
    2. Grow faster by learning from experience and each other, along with focused skills training
    3. Long term career in one of the fastest growing consumer health & hygiene company
    4. Make your mark and we will mark you for a global career
    5. Focus on doing, not deliberating

    You'll be part of a multicultural team where diversity is very high both in terms of gender and in terms of nationality, where performance and achievement are the common ground to build growth.

    Responsibilities:
    • Provide medical and scientific support to develop successfully medical, marketing & regulatory projects and launches for Medicines, Medical Devices, Cosmetics and Food Supplements (such as educational projects, clinical studies, medical reviews,…)
    • Develop and manage relationships with the detailing teams, trade associations and patients organizations on scientific/medical topics and Support them in medical inquiries
    • Drive and ensure Healthcare Compliance processes (e.g. samples, scientific communication, detailing, advertising and congresses management) as well as any contract with external suppliers providing activities
    • Ensure up to date knowledge of the local regulatory legislation / requirements and advise the GRA & GVG of changes as appropriate.
    • Prepare documentation and submission to ANMDM and Ministry of Health in compliance with current legislation to ensure efficient registration and maintenance of the registrations in accordance with business strategies with Manager support.
    • Analyze lifecycle of medicinal products and food supplements as per assigned brands: variations, Marketing Authorization renewals, labelling updates, artwork revision and approval.
    • Verify and approve documents which are prepared within the department and registration dossiers in the country or abroad
    • Verify and approve draft design for boxes, labels, foils and leaflets
    • Verify and approve applications for variations documentation both for products registered in the country, and those registered in the Balkan region

    Requirements:
    • Bachelor's Degree in a relevant Scientific discipline (Chemical Engineering, Chemistry, Pharmacy, Biochemistry, or similar)
    • Knowledge of regulatory and healthcare registration systems
    • Working experience within a laboratory environment of Regulatory Affairs is considered a plus.
    • Fluency in English

    Personal Attributes:
    • Fast learner
    • Result-oriented, entrepreneurial and self-motivating
    • Strong negotiating and interpersonal skills
    • Outgoing and dynamic personality with a high level of energy and drive

    Here in RB, we’re trusted with full accountability and autonomy from day one. Our entrepreneurial culture provides us with the opportunity to make a real difference. Our career possibilities are limitless because we’re not defined by rigid career paths.

    Each journey through RB is different – you can truly make your mark. If this sounds like you, we’d love to hear from you!

    The contract is on 1 year determined period.

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