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Regulatory Affairs Associate

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Summary of responsibilities:

  • Work collaboratively with the relevant Global teams and Country Commercial teams to implement the regulatory strategies within agreed timescales to bring competitive advantage to RB brands.
  • Ensure on-going regulatory and product safety compliance of RB’s existing product portfolio within the assigned Category segment(s).
  • Implement regulatory strategies that enable the delivery of a pipeline of product innovation to meet country requirements.
  • Ensure compliance with marketing authorisations and legal requirements for promotional material and artwork.
  • Understand and apply the RB processes and procedures as necessary.
  • Maintain and report on agreed key performance indicators.
  • Maintain Regulatory databases
  • Maintain Regulatory documentation
  • Support Deputy Quality Management Representative (Kvalitetsansvarlig)
  • Responsible for the Regulatory Affairs Excellence Project for the Nordic Medical product dossiers
Deputy QMR:
  • Implementation of current GDP legislation incl. Danish Legislation (BG on Distribution af lægemidler, Vejledning I GDP for lægemidler til humant brug, BG om udlevering af lægemiddelprøver) and maintenance of the overall QM System within RB Scandinavia.
  • Ensuring maintenance of the related instructions.
  • Handling all quality issues including ensuring that RB Scandinavia handles medical products according to current GDP-guidelines and legislation.
  • Support the handling of counterfeits products.
  • Support the approval of the rework and embellishment contractors.
  • Support the recall team consisting of the QMR, CMH and SCD and is responsible for managing product recall situations.
  • Document as well as train new employees in appropriate registration and quality knowledge
  • Ensure that all employees are familiar with the Training Records.
  • Archive the filled Training Records.
  • Ensure that the current valid SOPs and WIs related to their area always are available for the employees.
  • Keep up to date with current rules and guidelines within field of responsibility and GDP rules
  • University Science degree, ideally in a relevant Scientific discipline.
  • Experience from the pharmaceutical industry or health authorities: 1-2 years experience within regulatory affairs (medicinal products).
Other requirements:
  • Experience in the OTC market and within an FMCG environment, or within a pharmaceutical environment desirable.
  • Experience in devices and cosmetics regulations highly desirable
  • Knowledge of regulatory and healthcare systems in Scandinavian Region
  • Possesses excellent working knowledge of regulatory environment and processes in local markets.
  • Clear and logical thinker with the ability to recognise patterns and develop innovative solutions.
  • Pro-active self-direction with a high level of initiative and persistence and a very much hands on approach to results delivery.
  • Results oriented, entrepreneurial and self-motivating.
  • Capable of building strong working relationships
  • Commercial understanding of corporate and operational business issues.
  • Understanding of marketing strategy, planning issues, priority setting, project management.
  • Good communication skills both written and oral (in English, Danish and preferably Swedish or another Nordic language)
  • Openness to change and ability to think out of the box
  • Focus on details
  • Enjoy working in a fast- moving company
  • Understanding and insights are requirements: Possesses working knowledge of regulatory environment and processes in local markets. Have knowledge, experience and judgement sufficient to review dossiers and SOP’s. Ability to translate regulations and legislative activity into business solutions that result in increased brand value. Should be able to demonstrate experience in medicines regulations.
  • Please apply through the link with your CV and motivational letter
  • If any questions regarding the position, please contact Gergana.Ruseva@rb.com