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Clinical Trials Regulatory Associate Manager
Описание вакансии
Текст:
TL;DR
Clinical Trials Regulatory Associate Manager (Clinical Trials Regulatory Affairs): Supporting regulatory submissions and oversight across global clinical trial programs with an accent on CTIS, EU CTR compliance, scientific documentation, and stakeholder guidance. Focus on coordinating centralized and country submissions, reviewing IMPDs and clinical trial justifications, and managing complex regulatory deliverables throughout the trial lifecycle.
Location: Home-based in Belgrade, Serbia
Company
provides clinical research services, commercial insights, and healthcare intelligence for the life sciences and healthcare industries.
What you will do
- Serve as the Clinical Trial Regulatory Manager on complex clinical trial projects and programs.
- Provide regulatory oversight, strategic guidance, and recommendations to internal and external stakeholders.
- Prepare, author, and review regulatory documentation, including IMPDs and clinical trial justifications.
- Coordinate European centralized submissions and global country submissions, including CTIS activities during study start-up.
- Manage deliverables, records, tracking systems, and compliance with SOPs and regulatory requirements.
- Support business development, deliver regulatory training, and mentor junior team members.
Requirements
- Bachelor's degree in Life Sciences, Pharmacy, Regulatory Affairs, or a related field.
- Typically 3–5 years of Regulatory Affairs experience in the pharmaceutical, biotechnology, CRO, or clinical research industry.
- Current experience working with the EU CTR and CTIS, including direct oversight of CTIS during study start-up.
- Experience supporting clinical trial submissions and regulatory documentation.
- Strong scientific writing, document review, project management, analytical, and stakeholder engagement skills.
- Advanced knowledge of clinical trial regulations and regulatory submission processes.
Culture & Benefits
- Home-based work arrangement.
- Full-time employment supporting global clinical research programs.
- Opportunities to contribute to knowledge sharing, regulatory training, and professional collaboration.