Regulatory Affairs Specialist

For one of our clients, an international pharmaceutical company that has a regulatory affairs hub in Poland, we are looking for:

Regional Therapeutic Area Regulatory Affairs Specialist
Location: Warsaw
Work mode: Hybrid

Responsibilities:

• Plan and manage country rollouts by supporting dossier management and document translations.
• Act as a point of contact for dossier compilation to ensure that a ready-to-submit dossier is available as per the agreed plan.
• Provide relevant support for clinical trials, as applicable.
• Manage commitment and team culture towards business processes.
• Support the rollout of processes and projects for the region.
• Plan the scope for HA interaction and regulatory intelligence.
• Support the creation of TA regional strategy cross-functionally for rollouts.
• Infuse regulatory applications/documentation (dossier, promotional materials) with TA-specific expertise.
• Manage PSP and IST for marketed products and support management of critical HA notifications (e.g., review and document impact of incidents).
• Collaborate effectively across backgrounds/functions.
• Excellent knowledge of standard software (e.g., Microsoft Office, Spotfire).
• High proficiency in English is essential.

Requirements:

• University degree (Master's, PhD) in health-related science (preferably pharmaceutical) or an equivalent qualification with relevant work experience.
• 3-5 years of experience in the regulatory affairs field.
• Proven ability to communicate and collaborate with stakeholders from different backgrounds