Regulatory Affairs, Quality and Pharmacovigilance Manager

3 days ago

Budapest, Hungary Omega Pharma Hungary Kft. Full time
At Perrigo, we are driven by our mission to Makes Lives Better Through Trusted Health and Wellness Solutions, Accessible to All. We are proud to be a Top 10 player in the European Consumer Self-Care market and the largest U.S. store brand provider of over the counter and infant formula. Dedicated to providing The Best Self-Care for Everyone, we are the people behind the brands you trust. We are Opill®, Compeed®, Solpadeine®, NiQuitin®, ACO®, and many more. We Are Perrigo. We are committed to enhancing the wellbeing of our colleagues and consumers alike. We pride ourselves on fostering an inclusive, collaborative culture where each person can experience a sense of belonging.
 
Join us on our One Perrigo journey as we evolve to a blended-branded business to win in self-care., Regulatory Affairs, Quality and Pharmacovigilance Manager will be responsible for managing the RQS affiliate team and supervising external consultant responsible for quality. He will be managing licensing and post marketing activities for assigned Omega Pharma/Perrigo brands (among others: Coldrex, Niquitin, Paranit, Compeed, Ella One, etc). Working with multiple functions and external stakeholders (including authorities) across different product categories (medicinal products, cosmetics, food supplements, medical devices, biocides) in Hungary.
The role will be located at Budapest, Omega Pharma Hungary and will be reporting to head of Regulatory, Quality, Safety Central Easter Europe.

Main responsibilities:
  • Oversight for regulatory licencing and post marketing regulatory activities for all products registered and actively marketed in Hungary.  
  • Ensuring strategies and relationships with internal (e.g. GPS, CQA, Global Supply, CSCI Marketing,  Commercial) and external stakeholders (e.g. competent authorities in Hungary, external consultants).
  • Ensures company’s regulatory affairs activities are conducted according to relevant regulations, laws, and standards in the country.
  • Oversees and support quality assurance and pharmacovigilance activities in the region to ensure compliance with relevant regulations. Ensure that an QA/PV operating model is maintained according to the business needs in the region.
  • Ensure that optimal collaboration and ways of working are established and maintained with Corporate/ Global enabling functions
  • Ensures appropriate basis for implementation of regional/ local marketing strategies are identified and/or implemented; assists in identification of advanced regulatory strategies for regulatory classifications within scope.
  • Ensures that right processes and procedures are in place in the country.
  • Being accountable for the RA budget planning and monitoring in the country.
,
  • Minimum 7 years’ experience from the pharmaceutical/life science/selfcare industry, with a focus on regulatory affairs and understanding of quality assurance and pharmacovigilance as applying to OTC/ self-care products.
  • Must have leadership experiences and change management skills.
  • Ability to manage a team and direct reports in a hybrid model (on-site and remote.)
  • Must have experience from launching new self-care products and interactions with external stake holders.
  • Ability to manage cross-functional projects efficiently.
  • Proactive and results-oriented: takes ownership, can work independently, has a can-do attitude
, ,
  • Working with international teams and various internal and external stakeholders and being visible to senior levels of business
  • Constant personal development and learning various and diverse areas within regulatory, quality and safety fields
  • Participate in our unique and among the bests in Industry training programs regularly 
  • Competitive compensation package
  • Young, enthusiastic, helpful team
  • Hybrid work environment

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