Regulatory Affairs Associate (maternity cover)

PHOENIX Pharma
location_on гр. София

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Пълно описание


We are PHOENIX Pharma, part of PHOENIX Group - Europe’s leading pharmaceutical wholesaler, pharmacy operator and service provider for the pharmaceutical industry. 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. The vision of the PHOENIX Group is to be the partner of choice for simple and direct access to healthcare products and services across Europe.

At PHOENIX Pharma we share one cause – to contribute to the better future for healthcare. We believe that people are at the heart of our success.

People who share our ideas, take an active stance, and want to be better at everything, every day. If you believe in the culture of „growing together “and share our cause for the health of Bulgarian society, join us.

People we support, value, and develop. People to whom we offer not only the stability and security of a company that is a market leader and preferred international partner for direct access to healthcare services and products, but also the opportunity to contribute to our innovative business strategy and the ever-evolving technologies we create.

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.

Key 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 cope with complex tasks.


The company offers:

  • An opportunity to join a stable, international organization with a leading market presence across Europe;
  • A positive and supportive team of experienced professionals;
  • Comprehensive onboarding and initial training;
  • Real prospects for professional growth and long-term career development;
  • Additional health insurance, including dental coverage;
  • Monthly food vouchers worth 102,26 euro;
  • Sport cards at preferential rates;
  • Corporate discounts on various products and services;
  • Special gifts for personal and company occasions;
  • A flexible hybrid work model.


Please send us your recent resume if you recognize this role as a career opportunity for you. Only short-listed candidates will be contacted.

All applications will be treated in strict confidentiality.


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