Regulatory Affairs, Quality and Pharmacovigilance Manager
Budapest
Állandó 5-10 év szakmai tapasztalat Irodai munkavégzés
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:
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
