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Regulatory Affairs, Quality and Pharmacovigilance Manager

Budapest
Medical & Health Care
Permanent
Apply
Our partner company is an established player in the health sector with over 25 years of experience. They specialize in the development and distribution of over-the-counter medicines, medical devices, cosmetics, and dietary supplements. Their products are widely available in pharmacies and major retail chains across Hungary.
We are currently looking for a Regulatory Affairs, Quality and Pharmacovigilance Manager colleague.


Role summary:
  • Responsible for leading the Regulatory, Quality, and Safety (RQS) affiliate team in Hungary
  • Oversees external consultants managing local quality-related activities
  • Manages regulatory licensing and post-marketing activities for assigned brands
  • Collaborates with internal and external stakeholders, including regulatory authorities
  • Works across multiple product categories: medicinal products, cosmetics, food supplements, medical devices, and biocides

Key Responsibilities:
  • Lead and manage the RQS affiliate team in Hungary
  • Supervise external consultants responsible for local quality activities
  • Oversee all regulatory licensing and post-marketing regulatory operations for marketed products in Hungary
  • Ensure full compliance with local laws, regulations, and standards in all regulatory affairs activities
  • Maintain and develop strong relationships with internal  and external stakeholders (e.g. national competent authorities, external consultants)
  • Provide oversight and support for quality assurance and pharmacovigilance functions to ensure compliance with regulatory requirements
  • Establish and maintain an efficient QA/PV operating model aligned with business needs
  • Facilitate effective collaboration with corporate and global enabling functions
  • Support the implementation of local/regional marketing strategies from a regulatory perspective
  • Contribute to defining advanced regulatory strategies and appropriate product classifications
  • Ensure local regulatory processes and procedures are in place and continuously optimized
  • Be accountable for regulatory affairs budget planning and cost monitoring at the country level
Expectations:
  • Minimum 7 years of experience in the pharmaceutical, life sciences, or self-care industry, with a strong focus on regulatory affairs and solid understanding of quality assurance and pharmacovigilance related to OTC/self-care products
  • At least 2 years of experience in managing direct reports
  • Proven leadership experience, including demonstrated ability to lead through change and manage transformation processes
  • Experience in managing teams within a hybrid working environment (both on-site and remote)
  • Track record of successful self-care product launches and effective collaboration with external stakeholders (e.g. regulatory bodies, consultants, partners)
Preferences:
  • Strong ability to effectively manage cross-functional projects in a dynamic environment
  • Proactive and results-driven mindset, with a high sense of ownership and the ability to work independently
  • Demonstrates a positive, solution-focused attitude and a hands-on, can-do approach
Location:
  • Budapest
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