Regulatory Compliance Manager
Job Summary
Leading complex regulatory projects, the full-time Manager, Regulatory Registration and Compliance will develop regulatory strategies, prepare and review submissions for health authorities, and provide guidance and mentorship to junior team members while working remotely.
Key responsibilities
- Lead and coordinate regulatory projects to ensure compliance and timely delivery
- Develop regulatory strategies and provide expert guidance to stakeholders
- Prepare and oversee regulatory submissions and documentation for health authorities
Required qualifications
- University education in Natural Sciences, Chemistry, Medicine, Pharmacy, or Pharmacology
- Experience in the pharmaceutical, CRO, or regulatory sector, including leadership or project management roles
- Knowledge of EU regulatory requirements and ICH GCP/GVP standards
- Advanced knowledge of English (both written and verbal)
- Experience with regulatory databases and dossier management software is advantageous
Complete Job Description
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