Regulatory Affairs Specialist job opportunity at Zentiva.

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Zentiva Regulatory Affairs Specialist
Experience: General
Pattern: full-time
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degreeGeneral
loacation Portugal / Miraflores, Portugal
loacation Portugal / Mir..........Portugal

We are looking for a Regulatory Affairs & Medical Affairs Specialist to join our team in Portugal. This is a dynamic role combining Regulatory Affairs, Medical Affairs, and Market Access responsibilities. You will play a key role in supporting product launches, ensuring regulatory compliance, and driving pricing and reimbursement processes. RESPONSIBILITIES REGULATORY AFFAIRS: Develop and maintain a strong understanding of EU and Portuguese regulatory requirements. Prepare, submit, and track regulatory documentation in line with current legislation and company standards. Manage national procedures, translations, database validations, and communication with authorities. Ensure timely updates of Marketing Authorizations, labeling compliance, and inspection readiness. Build and maintain effective relationships with local regulatory authorities and relevant associations. Monitor regulatory changes and share critical updates with internal stakeholders.   MEDICAL: Review and approve educational, promotional, and non-promotional materials for compliance. Support training activities related to new product launches. Act as a liaison with external stakeholders, including Key Opinion Leaders.   MARKET ACCESS: Support pricing and reimbursement (P&R) submissions for retail and hospital products. Ensure compliance with national legislation, including annual price revisions. Follow internal pricing processes and international reference pricing (IRP) requirements. Must-Have Qualifications - Proven experience in Regulatory Affairs, including: DCP (Decentralised Procedure) MRP (Mutual Recognition Procedure) Portugal acting as RMS (Reference Member State) - Strong knowledge of national regulatory processes and authority interactions. - Experience with regulatory submissions, labeling, and compliance. Nice-to-Have - Experience in promotional material review and development. - Knowledge of Market Access processes (pricing and reimbursement). - Familiarity with advertising regulations for pharmaceutical products. Requirements - Degree in Pharmacy, Life Sciences, or related field. - Fluency in Portuguese and English (written and spoken). - Excellent organizational and communication skills.

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