Regulatory Affairs Manager M/F

at  Aixial

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.

Professional experiences, qualifications and skills required :

• Master degree in Life sciences (toxicology, pharmacy, chemistry,..)
• At least 5 years of work experience in the pharmaceutical sector and in Regulatory Affairs
• Knowledge and experience in Regulatory registration in EU countries
• Experience with generic medicines would be an asset
• Ability to work in a team and eager to learn
• Good communication, management and leadership skills
• Experience liaising with Health Authorities

Languages :

• Fluent in English and French (spoken and written) is mandatory
• A good level in Dutch would be appreciated

• 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