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.