Regulatory Affairs Manager
1 dzień temu
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.
- 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.
- 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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