Regulatory Affairs Director

2 tygodni temu


Gdańsk, Pomerania, Polska Antal Sp. z o.o. Pełny etat

**Regulatory Affairs Manager Position**

We are looking for a skilled Regulatory Affairs Manager to lead our team in delivering high-quality submissions and ensuring compliance with country-specific regulatory requirements.

Key Responsibilities:

  • Manage the hub site to deliver timely, high-quality submissions.
  • Serve as the main contact for client regional leads.
  • Implement and maintain compliance with country-specific regulatory requirements.
  • Develop and 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.
  • Closely monitor and address project audit findings within agreed timelines.
  • Oversee training record compliance.

Requirements:

  • Bachelor's or Master's degree in life sciences or pharmacy.
  • Significant 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).
  • At least 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:

  • A comprehensive benefits package.
  • An open-minded and multinational work environment.
  • The 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 job opportunities at: https://en.antal.pl/candidates



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