Regulatory Affairs Associate

Regulatory Affairs Associate

We are PHOENIX Pharma, a leading pharmaceutical distributor in Europe, every day we provide our clients with medicines and medical products that are always in the right place at the right time in all 29 countries where PHOENIX Group is represented. Thus, we contribute to the quality of health services we offer and to better healthcare throughout Europe. The vision of the PHOENIX Group is to be the best integrated healthcare provider – wherever it is active. In Bulgaria we operate more than 28 years on the pharmaceutical market holding a strong leading position.

We are looking for a Regulatory Affairs Associate colleague to support HALEON (former GSK Consumer Healthcare) business.This position has responsibility for Regulatory Affairs in defined consumer healthcare portfolios (OTC medicines, medical devices, cosmetics, and food supplements) or activity stream in Bulgaria.

Responsibilities:

  • Manage preparation of new regulatory documents, dossiers and applications to enable new products to be launched and maintained in market, with the correct alignment and compliance to regulations;
  • Manage compliance within portfolio/activity streams in line with company expectations – support key processes and ways of working;
  • Support the development of the strongest claims/advertising and promotion possible withing regulations, ensuring risks are appropriately addressed and communicated;
  • Proactively manage impact of regulatory changes within defined scope of responsibility on the business;
  • Work closely with cross-functional colleagues to align on strategy;
  • Maintain required regulatory compliance databases, systems and processes;
  • Review, correct and approve the artworks, review and approve promotional materials;
  • Support in the maintenance of global and local regulatory trackers and databases;
  • Monitor the external regulatory environment and changes in the national legislations
  • Provide national input to and execute regulatory strategies;
  • Act as point of contact with regulatory agencies in fulfilling local obligations;
  • Participates in local regulatory processes, improvements, initiatives and trainings.

Requirements:

  • Life science master’s degree;
  • 2-3 years experience in regulatory affairs;
  • Knowledge of regulatory principles;
  • Good understanding of local regulatory environment ;
  • Fluent English knowledge;
  • Ability to use IT platforms and MS tools;
  • Ability to communicate scientific information;
  • Meeting deadlines and enable to coop with complex tasks.
Our offer

Work in a well-established multinational company with a strong entrepreneurial culture;

A positive and supportive team of professionals

Training introducing the nature of the work

Motivating remuneration plus bonuses and food vouchers

Additional health insurance with dental package

    Application form

    If you are interested in joining our company and meet the stated requirements for this position, please send us your resume. Only shortlisted applicants will be contacted.

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