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Regulatory Affairs, Quality and Pharmacovigilance Manager
Budapest
Permanent
ApplyOur 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:
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
