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Regulatory affairs manager

Dublin
Cpl Resources - Science & Engineering
Regulatory affairs manager
Posted: 4 December
Offer description

Regulatory Affairs Manager x 2 - Contract 12 / 24 month Were seeking 2 experienced Regulatory Affairs Managers to support global regulatory strategy and ensure timely, compliant submissions across a diverse product portfolio, covering commercial and clinical products. Key Responsibilities: Lead or support regulatory strategy for new MAAs and post-approval changes Collaborate with local regulatory teams and Health Authorities Prepare and review dossiers and submission components Maintain regulatory databases and project records Build strong relationships with internal teams and external partners Contribute to due diligence and cross-functional initiatives About You: Degree in Life Sciences / Pharmacy (MSc/PhD a plus) Significant experience in Regulatory Affairs Strong communication, organisation, and prioritisation skills Comfortable working in fast-paced, high-volume environments Experience mentoring or supporting junior colleagues If youre purpose-driven and ready to make an impact in global healthcare, wed love to hear from you. #LI-SD1 Skills: regulatory affairs MAA quality compliance CMC

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