Biomapas

Compliance

• - 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.

Local Regulatory Affairs Manager – Freelance/Part-time

• 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.