Regulatory Affairs Associate

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Employer: Reckitt Benckiser
Domain:
  • Quality Control
  • Pharmacy - Health
  • Administrative Assistance
  • Job type: full-time
    Job level: 1 - 5 years of experience
    Location:
  • BUCHAREST
  • Updated at: 08.11.2018
    Short company description

    RB is a global success story in Health, Hygiene & Home giving people innovative solutions for healthier lives & happier homes.
    Its strong achievement and entrepreneurial focused culture is renowned for giving employees unparalleled ownership of projects and decisions and where international mobility is encouraged.
    RB's an organisation where driven people thrive. It’s a FTSE top 15 company and since 2000 net revenues have doubled and the market cap has quadrupled.
    Today it is the global No 1 in the majority of its fast-growing categories, driven by an exceptional rate of innovation – over a third of revenue comes from innovations launched in the prior 3 years.
    It has a strong portfolio led by 19 global powerbrands, such as Dettol, Finish, Airwick, Mucinex, Lysol, Vanish, Veet, Nurofen and Strepsils which account for nearly two thirds of its net revenue.


    Requirements

    PROFESSIONAL QUALIFICATIONS / EXPERIENCE
    •University Science degree in a relevant Scientific discipline (Chemical Engineering/Chemistry/Pharmacy/Biochemistry).
    •Broad knowledge of regulatory and healthcare registration systems.
    •Minimum 1 year experience working within a laboratory environment or Regulatory Affairs.
    •Ability to understand and interpret directives and regulatory guidelines and communicate them effectively to the relevant stakeholders.


    PERSONAL ATTRIBUTES
    •Ability to work in an international environment
    •Result-oriented, entrepreneurial and self-motivating
    •Strong negotiating and interpersonal skills
    •Commercial understanding of operational business issues
    •Understanding of marketing strategy and planning issues
    •Ability to transform solid thinking into action
    •Openness to change and ability to think out of the box
    •Fluency in English

    Responsibilities

    SUMMARY OF RESPONSIBILITIES

    Main objective of the role is delivering the regulatory strategy for the assigned projects in the country.

    The RA Associate will focus on:
    •Preparation of documentation and submission to the corresponding Authorities in compliance with current legislation to ensure efficient registration, notification and maintenance of the registrations in accordance with business strategies with the support of the Manager.
    •Maintenance of documentation for Home & Hygiene products as per assigned brands: Artwork revision, Documentation updates (PSDS), detergents’ website maintenance, PCI notification etc.
    •Review advertising and promotional activities and prepare submission for approval to MoH for Medical Devices and PMC/Biocides.
    •Maintaining and processing of regulatory databases.

    Other info

    As Regulatory Affairs Associate for divisions Home, Hygiene

    …..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.

    …you’ll have responsibility for the implementation of regulatory practices across defined categories. Adhering to Global standards and local procedures, you’ll help providing safe, effective and compliant products to customers, consumers and patients, as well as accurate and consistent information to internal and external stakeholders.