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Local Regulatory Affairs Manager Benelux (Freelance/Part-time) at Biomapas. Freelance opportunity . in Benelux! Join our global team as a . Local Regulatory Affairs Manager . in Belgium, Netherlands and Luxembourg. . 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 0.35 FTE) and covers the Benelux region, 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.  . 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.  . Biologist, Pharmacist, Medical Doctor, or other life science degree . Fluent written and spoken English, German, Dutch, French and Luxembourgish . At least 2 years of experience in local regulatory affairs activities . Experience with local documents preparation and regulatory submissions  . Excellent knowledge of local and international regulations (including knowledge concerning orphan medicinal products and the market entry aspects of centrally authorized medicines) . High motivation to develop and learn within the team . Company Location: Luxembourg.