Regulatory Affairs Specialist

Job title:

Company:

Morgan Philips

Job description

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: HybridResponsibilities:

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