Freelance opportunity in Romania! Join our global team as a Local Regulatory Affairs Specialist in Romania.
Local Regulatory Affairs Specialist 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 0.1FTE) and covers Romania, 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 Specialist 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 (including submission of educational materials and local notifications).
- 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 and proofreading.
- 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 Romanian
- At least 2 years of experience in local regulatory affairs activities
- Proven experience managing local Regulatory Affairs activities in Romania 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