Remote Senior Regulatory Submissions Lead (Contract)

Planet Pharma; Madrid; Hybrid; EUR 90,000 - 120,000; Full time

Job summary

Planet Pharma is seeking a Senior Regulatory Submissions Lead to guide regulatory strategies for clinical studies across regions. You will oversee CTIS submissions, coordinate with sponsors and cross-functional teams, and drive compliant study initiation and maintenance.

Ideal candidates have 8–10 years in regulatory submissions, strong ICH/GCP knowledge, and a proven track record in global trials. This contract role offers flexible remote work within Europe and opportunities to mentor staff.

Qualifications

• 8–10 years in regulatory submissions, incl. 6+ years in lead/manager roles on global trials.
• Proven experience managing CTIS submissions and cross-country registrations.
• Strong knowledge of ICH/GCP, FDA, EU regulations and guidelines.
• Bachelor’s degree in a related field (pharmacy/medicine/science).
• Excellent organizational skills and detail orientation.
• Collaborative mindset with strong communication and customer focus.

Responsibilities

• Develop and manage regulatory strategies and start-up plans for clinical studies.
• Lead CTIS activities for EU interventional studies and ensure compliance with evolving regulations.
• Serve as primary regulatory contact for sponsors, communicating timelines and deliverables clearly.
• Prepare and review submission documentation, informed consent forms, and country packages.
• Coordinate with Study Start-Up to define templates and site activation strategies.
• Monitor regulatory developments and drive process improvements across the team.

Skills

Regulatory leadership

CTIS submissions

Cross-country collaboration

Regulatory strategy

Communication

Education

Bachelor’s degree in pharmacy/medicine/science

Tools

CTIS platform

Regulatory databases

Job description

Planet Pharma is seeking a Senior Regulatory Submissions Lead to guide regulatory strategies for clinical studies across regions. You will oversee CTIS submissions, coordinate with sponsors and cross-functional teams, and drive compliant study initiation and maintenance.

Ideal candidates have 8–10 years in regulatory submissions, strong ICH/GCP knowledge, and a proven track record in global trials. This contract role offers flexible remote work within Europe and opportunities to mentor staff.