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

<p><strong>Freelance opportunity in Romania!</strong> Join our global team as a Local Regulatory Affairs Specialist in Romania.</p> <p><strong>Local Regulatory Affairs Specialist</strong> 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.</p> <p><u><strong>The position is remote (approximately 0.1FTE) and covers Romania, </strong></u><u>working in close collaboration with the Regulatory Affairs team. </u></p> <p><u><em>You have energy and motivation to work in a team and to gain more experience? </em></u></p> <p><u><em>Submit your CV in the English language for consideration.</em></u></p> <p><strong>Responsibilities:</strong></p> <ul> <li>Act as Local Regulatory Affairs Specialist in the assigned territory.</li> <li>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.</li> <li>Maintain timely and effective communication with local Competent Authorities.</li> <li>Monitor and report changes in national regulatory requirements on a regular basis.</li> <li>Develop and/or review of regulatory strategy to support product lifecycle planning, including initial market entry and post-approval changes.</li> <li>Prepare regulatory documentation for submission to Competent Authorities. Regulatory submissions (including submission of educational materials and local notifications).</li> <li>Regulatory review for labelling components (e.g., packaging, patient leaflets, SmPC), promotional materials, and product information to ensure full compliance with applicable regulatory requirements.</li> <li>Translations and proofreading.</li> <li>Ensure accurate documentation, reporting, and follow-up of all regulatory reports.</li> <li>Support Biomapas Clients with other RA-related tasks, including strategic and operational regulatory advice.</li> </ul> <p><strong>Requirements</strong></p> <ul> <li>Biologist, Pharmacist, Medical Doctor, or other life science degree</li> <li>Fluent written and spoken English and Romanian</li> <li>At least 2 years of experience in local regulatory affairs activities</li> <li>Proven experience managing local Regulatory Affairs activities in Romania for MP, MD and FS</li> <li>Experience with local documents preparation and regulatory submissions </li> <li>Excellent knowledge of local and international regulations</li> <li>High motivation to develop and learn within the team</li> </ul>