Regulatory Affairs Associate

Job Summary:

The Clinical Trial Submission Lead (CTSL) is responsible for end-to-end planning, coordination, and execution of Clinical Trial Applications (CTA) across EU CTR and Rest of the World (ROW) regions. This role ensures timely, high-quality, and compliant submissions through effective cross-functional collaboration, proactive risk management, and strong regulatory expertise.

Key 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 3+ 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

Key Skills:

• Project Management & Execution

• Regulatory Knowledge (EU CTR & Global Submissions)

• Risk & Issue Management

• Stakeholder Engagement

• Strong communication and problem-solving skills

• Adaptability, resilience, and teamwork