Regulatory Affairs Manager

1 dzień temu


Gdańsk, Pomerania, Polska Antal Sp. z o.o. Pełny etat
Regulatory Affairs Manager

Antal Sp. z o.o. is seeking a highly skilled Regulatory Affairs Manager to lead teams of Regulatory Specialists in Poland.

Key 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.
What 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.

Check out other interesting jobs on: https://en.antal.pl/candidates



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