Senior Regulatory Affairs Associate – Clinical Trial Application
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Job Description
Clinical Trial Submission Lead managing and executing Clinical Trial Applications globally. Ensuring compliant submissions across multiple studies with effective team collaboration and stakeholder engagement.
Responsibilities:
- Lead end-to-end CTA project management across multiple studies and countries
- Plan, track, and deliver submissions aligned with timelines and regulatory requirements
- Manage risks, dependencies, and complexities in global regulatory environments
- Apply knowledge of EU CTR and ROW CTA requirements
- Manage core clinical and regulatory documentation
- Collaborate with cross-functional global teams
- Build and maintain stakeholder relationships and resolve conflicts
- Monitor KPIs related to timelines and deliverable quality
- Identify risks and lead quality investigations as needed
Requirements:
- Bachelor’s degree in Life Sciences, Pharmacy, or related field
- Minimum 5+ years of industry experience in pharmaceutical, CRO, or similar
- Experience in Clinical Trial Application submissions (EU CTR & ROW)
- Strong project management experience in a global/matrix environment
- Familiarity with clinical trials and regulatory processes
Benefits:
- Remote working arrangements
- Opportunities for professional development
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