global cmc regulatory affairs specialist

☞ Randstad

View: 115

Update day: 26-11-2025

Location: Beerse Antwerp

Category: Executive management Marketing / PR Mechanical / Technical Maintenance

Industry: HR personeel

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Job content

As CMC Regulatory Affairs you will be responsible for one or more commercial and/or development small molecule compounds for all markets worldwide for this pharma giant. Interested? Apply now at soraya.benaissaoui@professionals.randstad.be or call me on +32 2 472 94 70

    qualifications

    • direct and significant cmc regulatory experience with post approval amendments and variation dossiers for small molecules worldwide.
    • strong knowledge of global/worldwide regulatory guidelines and regulations is required.
    • experience in supporting health authority meetings (fda & apac is a plus, ema is a must) preferred.
    • demonstrated ability to manage multiple tasks/projects/priorities and complex systems simultaneously is required.
    • strong interpersonal, teamwork, leadership, conflict management, fast learner and negotiation skills are essential. the candidate must be able to motivate people within a matrix team environment as an individual contributor, decision maker, and leader.
    • excellent knowledge of english (written & spoken).
    remote work possible, max once a month on site (beerse).

    key responsibilities

    you will be cmc regulatory affairs responsible for one or more commercial and/or development small molecule compounds for all markets worldwide.

    • you will actively participate in several development and other teams
    • post-approval cmc ra activities will include providing direction on the interpretation and application of global cmc regulations and guidelines for cmc changes including country specific requirements, defining regulatory strategy, writing cmc variation dossiers and coordinating responses to health authorities (ha)
    • development activities will include: contribution to the preparation and editing of clinical trial and initial marketing applications and coordinating responses to ha; correspondence and direct interaction with ha; development of product-specific regulatory strategy documents; technical review and approval of master protocols, reports and other source documents; and other related duties as assigned

    key benefits

    as an answer to your high performance & flexibility, ausy offers you an interesting salary package, with some interesting extras 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 skills and become an even bigger expert!
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Deadline: 10-01-2026

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