Regulatory affairs manager

☞ AUSY, a Randstad company

Vue: 140

Jour de mise à jour: 26-11-2025

Localisation: Antwerp City Antwerp

Catégorie: Direction

Industrie:

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le contenu du travail

We are looking for a regulatory affairs manager who has excellent skills in negotiating and conflict handling and complex project management skills.

You can apply for this challenging opportunity at: sarah.leten@professionals.randstad.be or call me: 0489/789720


  • University degree     - medical or paramedical (pharmacy, biology, veterinary etc.), or equivalent by experience
  • Breadth ofregulatory experience in drug development and commercialization of vaccines
  • Experience with EU regulatory procedures
  • Excellent knowledge of English
  • In depth knowledge of the regulatory environment, guidelines and practice of EMEA regions


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


Do you believe in affordable healthcare? Are quality & safety your priority number 1? Then you’ll feel comfortable in this company, who’s one of the biggest pharmaceutical companies in the world.

This is a 100% remote project.


  • Advise the Project Team and/or Regional Therapeutic Area Leader on applicable regulatory issues, project-specific regulatory issues, and issues related to regional regulatory climates
  • Develop a deep understanding of the regional regulatory environment, competitor intelligence and therapeutic area
  • Establish and maintain strong relationships with Regulatory Agencies and effectively negotiate with Regulatory Agencies on product-specific labeling, study design, submissions content, and post-approval commitments
  • Prepare team,manage, conduct and facilitate contacts/meetings with Regulatory Agencies. Define attendance in consultation with GRL and CDT. Issue minutes and contact reports and disseminate correspondence, faxes, contact reports from contacts with Regulatory Agencies
  • Provide input to and review submission documents to ensure that they are fit for purpose and support labeling statements as appropriate
  • Ensure protocols are developed in alignment with regional registration strategies to support registration, reimbursement and competitive labeling
  • Manage submissions, define submission plans, and advise team on equired documents and submission strategies in preparation of MAAs
  • Determine resource requirements for assigned projects and anticipate needs for major filings
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Date limite: 10-01-2026

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