Local Regualtory Affairs Specialist in Romania (Freelance/ 0.1 FTE)
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About the Role
Join a global team as a Local Regulatory Affairs Specialist in Romania on a freelance, remote basis. This position is approximately 0.1 FTE and focuses on ensuring medicinal and other products comply with applicable regulatory requirements through expert input and coordination of marketing authorization and post-authorization activities.
Responsibilities
- Act as the 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 the 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 regulatory strategy to support product lifecycle planning, including initial market entry and post-approval changes.
- Prepare regulatory documentation for submission to Competent Authorities, including submissions for educational materials and local notifications.
- Conduct regulatory reviews for labeling components (e.g., packaging, patient leaflets, SmPC), promotional materials, and product information to ensure full compliance.
- Perform 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
- Degree in Biology, Pharmacy, Medicine, or another life science field.
- 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 document preparation and regulatory submissions.
- Excellent knowledge of local and international regulations.
- High motivation to develop and learn within the team.
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Job Overview
FAQ
Is this position remote?
The Local Regualtory Affairs Specialist in Romania (Freelance/ 0.1 FTE) role is a remote opportunity. The location specified is Romania.
What is the salary?
The salary is not explicitly stated, but is competitive and based on experience.
How do I apply?
You can apply by clicking the "Apply for this role" button above to submit your application on the hiring website.