Regulatory Affairs & Pharmacovigilance Specialist (CEE)

About the role

ProPharma is seeking a Regulatory Affairs and Pharmacovigilance Specialist to support its Central and Eastern European (CEE) operations. The role combines regulatory submission expertise with pharmacovigilance monitoring to ensure product compliance across the EU and local markets.

Key responsibilities

• Prepare and submit regulatory applications, variations, notifications, and renewals for medicinal and non‑medicinal products.
• Draft supporting documentation for market placement, product recalls, pricing, and reimbursement activities.
• Review marketing materials for compliance with registered dossiers and local legislation.
• Communicate and negotiate with Competent Authorities (CA) on regulatory requests.
• Monitor local and EU regulatory and pharmacovigilance legislation, informing internal teams and contractual partners of changes.
• Provide consultancy and advisory support on locally specific regulatory topics.
• Develop training materials, deliver training sessions, and supervise junior RA staff.
• Participate in regulatory audits, inspections, and maintain accurate documentation archives.

Required profile

• Proven experience in regulatory affairs and pharmacovigilance within the pharmaceutical or medical device sector.
• Strong knowledge of EU and local regulatory frameworks, including CA procedures.
• Excellent written and verbal communication skills for interaction with authorities and partners.
• Ability to work independently and as part of cross‑functional product teams.

Required skills

• Regulatory submission preparation
• Pharmacovigilance case handling
• Legislation monitoring
• Training material development