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Regulatory Affairs Manager M/F
il y a 1 semaine
You are a highly skilled professional with passion for the world of Life Sciences and Clinical Research ? You want to thrive in a dynamic and collaborative international environment where your expertise directly impacts people lives?
Come and join Aixial Group to contribute to shaping the future of clinical research
Aixial Group is currently hiring a Regulatory Affairs Manager for a position based in Brussels .
As a Regulatory Affairs Manager , you will lead the registration of a portfolio in Europe.
Your tasks will be to (non-exhaustive list):
- Evaluate the specificities and regulatory requirements of the European markets
- Work with the Regulatory Management team, Regulatory Affairs colleagues, and cross-functional team to assess the feasibility, contribute to the analysis of regulatory, commercial, and market access aspects and develop and implement strategies that will ensure the timely introduction of the product onto EU market.
- Compile, write and submit the dossiers.
- Manage communications with regulatory authorities.
- Contribute and coordinate packaging development.
- Review of product marketing materials to ensure conformity with product claims.
- Monitor and communicate regulatory requirements in EU to ensure preparedness for upcoming submissions.
- Provide technical expertise to project teams.
- Conduct training on European regulatory requirements for internal teams
- Provide regular updates on the project's progress to internal stakeholders.
