Senior Regulatory Affairs Associate- Clinical Trial Application

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
• Qualifications & Experience:
• 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

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Company Intel

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