Regulatory Affairs

17-9-2019 ixelles
company profile

We are looking for a regulatory affairs specialist with experience in the pharmaceutical industry

Whether you are looking for a project based contract, a contract of indefinite duration or an opportunity to work as a freelancer, look no further. It is all possible here, at AUSY.

Interested? Send me an up-to-date resume: anais.bosmans@cx.ausy.be or call 03 200 28 01

job description

Are you the regulatory affairs specialist we are looking for? 

Do you have experience in the pharma and CMC? 

Then this is the vacancy for you! 

What is expected of you? 

  • Execution of European Regulatory CMC strategies, submissions and compliance activities for bio-pharmaceutical projects/products from development to market and post-marketing, including the preparation and submission of correspondence and applications to regulatory agencies
  • Preparation of CMC information for submission to EU regulatory agencies
  • Generates CMC strategies, assesses risks and develops contingency plans
  • Ensures that CMC regulatory submissions are complete, properly formatted, and comply with applicable regulatory requirements
  • Depending on experience, may act as CMC representative in formal meetings and teleconferences with regulatory authorities
  • Compilation of files following local regulatories  + follow-up + maintenance for Vaccines 


your contribution

  • Scientific degree in a relevant subject
  • 3-5 years international regulatory experience in CMC or in Quality Assurance
  • International Regulatory experience for full registration Vaccines dossiers
  • Ability to interpret and apply global / regional CMC regulatory policies and requirements for assigned projects
  • May operate  independently to resolve issues and manage regulatory risks and ambiguous situations within project teams
  • Leadership skills, influencing and persuading skills
  • Excellent cross-cultural awareness and understanding
  • Fluency in the English Language is essential

what do we offer?

As an answer to your high performance & flexibility, Ausy offers you an interesting salary package, with some interesting extra's like:

• Meal vouchers of €7
• Net representation cost of €50
• Hospitalization insurance
• Car + unlimited fuel card OR home-work compensation
• 32 holidays
• End-of-year bonus
• Pension plan
• ECO vouchers
• Opportunities to follow trainings

And on top of this you'll improve your administrative skills and become an even bigger expert!

summary
function
project manager (m/f)
employment type
full time, freelance
contract type
immediate permanent employments
reference
CXRSP-84365
your Randstad contact
Anaïs Bosmans
Anais_Bosmans@cx.ausy.be 03 200 28 01
03 200 28 01