Informacje o stanowisku

For the client - one of the largest pharmaceutical companies, we are looking for a Regulatory Affairs Manager to lead teams of Regulatory Specialists in Poland.

Responsibilities:

• Lead the hub site to deliver timely, high-quality submissions.
• Serve as the main contact for client regional leads.
• Ensure compliance with country-specific regulatory requirements.
• Establish new processes and documentation.
• Manage team attrition, resources, and budget effectively.
• Proactively address concerns with the Engagement Manager.
• Ensure team compliance with the general training plan and mandatory courses.
• Close project audit findings within agreed timelines.
• Oversee training record compliance.

Requirements:

• Bachelor’s or Master’s degree in life sciences or pharmacy.
• Experience in Regulatory Affairs for Pharmaceuticals, Biologics, Chemicals, or Medical Devices.
• Familiarity with regulatory publishing tools (eCTDXpress, ISI toolbox, Firstdoc, Insight publisher).
• Experience with US and EU submissions (CTD/eCTD/NeeS).
• 6-10 years in Regulatory Operations and Document Publishing.
• Knowledge of 21 CFR part 11 and Good X Practice (GxP).
• Preferred skills: experience in submission publishing and emerging markets, as well as regulatory affairs certification.

We offer:

• Extensive benefits package: Multisport Card, LuxMed medical healthcare including dental care, life insurance, cafeteria benefits.
• Open-minded and multinational environment.
• Opportunity to be part of a global organization focused on development.
• Professional development and a clear career path.
• Training & development opportunities including language courses.

Gdańsk - Oferty pracy w okolicznych lokalizacjach