Regulatory Affairs Consultant

Regulatory Affairs Manager – Remote (Poland or EU)

Location : Remote (based in Poland or EU)

Contract Type : 12-month contract, with possibility of extension

Workload : Part‑time (20h / week) or Full‑time

Start Date : ASAP

We are looking for an experienced Regulatory Affairs Manager to support ongoing regulatory operations and submissions within Poland and across EU markets. This is a great opportunity to join a collaborative international environment and contribute to life cycle maintenance and compliance activities.

Key Responsibilities :

• Manage and update country‑specific regulatory documents (SmPC, PIL, PI, label deviations).
• Oversee submissions, renewals, and variations (MRP / DCP, PSURs, Article 61(3)) in line with EU requirements.
• Support MAAs and maintain current regulatory intelligence across assigned markets.
• Act as the main point of contact for internal stakeholders, third parties, and local health authorities.
• Review SOPs, translations, and artworks to ensure alignment with global CCDS and labeling standards.

What We’re Looking For :

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