Regulatory Affairs Manager H/F

Aixial Group, CRO (Clinical Research Organization), specialized in Life Sciences. We work with laboratories to provide technical support on clinical projects from phases I to IV and post market.​

Since 2014, we have been part of the Alten family. We are developing our activities in France, Belgium, Switzerland, Czech Republic, Denmark, UK, US…with even more prospects for expanding internationally.​

Aixial Group, operates in outsourcing, insourcing, for pharmaceutical, cosmetic, medical device, biotechnology, nutrition,… industries in clinical operations, regulatory affairs, quality, biometrics, pharmacovigilance, HEOR…activities.

Aixial Group continues to grow, and to recruit in the clinical trial professions. Come and join us, and discover our website to follow the news of our offers:https://www.aixialgroup.com/join-us/​

For more information: https://www.linkedin.com/company/aixialgroup/about/​​

Aixial Group is currently hiring a Regulatory Affairs Manager M/F for an hybrid 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