Biomapas
Biotechnology • Pharmaceuticals • Healthcare Insurance
Biomapas is a comprehensive outsourcing solution provider catering to the global life science sector. The company acts as a strategic partner for biopharmaceutical and medical device companies, offering extensive clinical research services worldwide. Biomapas covers the entire product lifecycle from regulatory compliance to pharmacovigilance and medical information. The company operates across various regions including Europe, CIS, EAEU, MENA, LATAM, and the US, ensuring high-quality, efficient, and cost-effective methodologies to deliver superior service and strategic advantages. With a focus on clinical trials, pharmacovigilance, and regulatory affairs, Biomapas is equipped to navigate complex regulatory environments and manage clinical trial data effectively, contributing to clients' commercial success.
Local Regulatory Affairs Manager – Freelance/Part-time
Job not on LinkedIn
November 4
🗣️🇪🇸 Spanish Required
Biomapas
Biotechnology • Pharmaceuticals • Healthcare Insurance
Biomapas is a comprehensive outsourcing solution provider catering to the global life science sector. The company acts as a strategic partner for biopharmaceutical and medical device companies, offering extensive clinical research services worldwide. Biomapas covers the entire product lifecycle from regulatory compliance to pharmacovigilance and medical information. The company operates across various regions including Europe, CIS, EAEU, MENA, LATAM, and the US, ensuring high-quality, efficient, and cost-effective methodologies to deliver superior service and strategic advantages. With a focus on clinical trials, pharmacovigilance, and regulatory affairs, Biomapas is equipped to navigate complex regulatory environments and manage clinical trial data effectively, contributing to clients' commercial success.
📋 Description
• - 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.
🎯 Requirements
• - Biologist, Pharmacist, Medical Doctor, or other life science degree • - Fluent written and spoken English and Spanish • - 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
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