Local Regualtory Affairs Specialist in Romania (Freelance/ 0.1 FTE)

Local Regulatory Affairs Specialist - Romania (Freelance, 0.1 FTE)

Biomapas is seeking a motivated and experienced Local Regulatory Affairs Specialist to join our global team. This is a remote, freelance opportunity (approximately 0.1 FTE) focused on the Romanian market.

About the Role

As a Local Regulatory Affairs Specialist, you will play a crucial role in ensuring that medicinal products, medical devices, and other products comply with all applicable regulatory requirements in Romania. You will provide essential input and coordinate marketing authorization and post-authorization activities, working closely with our international Regulatory Affairs team.

Key Responsibilities

• Act as the primary Local Regulatory Affairs Specialist for the assigned territory (Romania).
• Oversee and manage all local Regulatory Affairs activities for Medicinal Products (MP), Medical Devices (MD), and Food Supplements (FS), ensuring full compliance with the Romanian regulatory framework.
• Maintain timely and effective communication with local Competent Authorities.
• Regularly monitor and report on changes in national regulatory requirements.
• Develop and/or review regulatory strategies 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 of labelling components (e.g., packaging, patient leaflets, SmPC), promotional materials, and product information to ensure compliance.
• Perform translations and proofreading of regulatory documents.
• Ensure accurate documentation, reporting, and follow-up of all regulatory reports.
• Support Biomapas clients with other Regulatory Affairs-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.
• Minimum of 2 years of experience in local regulatory affairs activities.
• Proven experience managing local Regulatory Affairs activities in Romania for Medicinal Products, Medical Devices, and Food Supplements.
• Demonstrated experience with the preparation of local documents and regulatory submissions.
• Excellent knowledge of local (Romanian) and international regulations.
• High motivation to develop and learn within a team environment.

If you are energetic, motivated, and eager to gain more experience in a dynamic international setting, we encourage you to submit your CV in English.