Freelance opportunity in Poland! Join our global team as a Local Regulatory Affairs Manager in Poland.
Local Regulatory Affairs Manager will be responsible for ensuring that medicinal and other products comply with applicable regulatory requirements by providing input and coordinating marketing authorization and post-authorization related activities.
The position is remote (approximately 0.25 FTE) and covers the Poland, working in close collaboration with the Regulatory Affairs team.
You have energy and motivation to work in a team and to gain more experience?
Submit your CV in the English language for consideration.
Responsibilities:
- Act as Local Regulatory Affairs Manager in the assigned territory.
- Oversee and manage all local Regulatory Affairs activities related to Medicinal Products (MP), Medical Devices (MD), and Food Supplements (FS), ensuring full compliance with applicable regulatory framework.
- Maintain timely and effective communication with local Competent Authorities.
- Monitor and report changes in national regulatory requirements on a regular basis.
- Develop and/or review of regulatory strategy to support product lifecycle planning, including initial market entry and post-approval changes.
- Prepare regulatory documentation for submission to Competent Authorities. Regulatory submissions.
- Regulatory review for labelling components (e.g., packaging, patient leaflets, SmPC), promotional materials, and product information to ensure full compliance with applicable regulatory requirements.
- Translations.
- Ensure accurate documentation, reporting, and follow-up of all regulatory reports.
- Support Biomapas Clients with other RA-related tasks, including strategic and operational regulatory advice.
Requirements
- Biologist, Pharmacist, Medical Doctor, or other life science degree.
- Fluent written and spoken English and Polish.
- At least 2 years of experience in local regulatory affairs activities.
- Proven experience managing local Regulatory Affairs activities in Estonia for MP, MD and FS.
- Experience with local documents preparation and regulatory submissions.
- Excellent knowledge of local and international regulations.
- High motivation to develop and learn within the team.
