Clinical Trial Regulatory Submission
Remote Full-time Pharmaceuticals & Biotech Associate
Job Title: Clinical Trial Submission Lead (CTSL)
Overview
The Clinical Trial Submission Lead (CTSL) is responsible for the end-to-end planning, coordination, and execution of Clinical Trial Applications (CTA) across EU CTR and Rest of World (ROW) regions. The 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.
Required Qualifications
- Bachelor’s degree in Life Sciences, Pharmacy, or a related field.
- Minimum 5+ years of industry experience in pharmaceutical, CRO, or similar environments.
- Experience in Clinical Trial Application submissions, including EU CTR and ROW.
- Strong project management experience in a global/matrix environment.
- Familiarity with clinical trials and regulatory processes.
- Strong communication and problem-solving skills.
Preferred Qualifications
- Project management and execution experience.
- Regulatory knowledge covering EU CTR and global submissions.
- Risk and issue management experience.
- Strong stakeholder engagement skills.
- Adaptability, resilience, and teamwork.