Regulatory Submissions Lead for CTAs & CTIS

ICON Strategic Solutions; Poland; On-site; PLN 240,000 - 360,000; Full time

Benefits offered by this job

Health insurance

Competitive retirement planning

Global Employee Assistance Programme

Job summary

ICON Strategic Solutions is seeking a Regulatory Submission Manager to lead regulatory submissions for CTAs globally. The role sits in the Regulatory Affairs team and acts as regional representative within study teams.

You will manage translation coordination, core document gathering, and cross-functional collaboration with sponsors, SSU, and study management to ensure timely, compliant submissions.

Qualifications

• Extensive experience with CTIS for document uploads and/or Veeva.
• CTA and Central Ethics processes knowledge.
• Education in Pharmacy or Life Sciences and related fields.

Responsibilities

• Drive global submission management strategy for assigned protocols and regulatory deliverables.
• Lead meetings to set realistic timelines and monitor submission status.
• Ensure high-quality submissions compliant with guidelines, policies, and timelines.
• Coordinate core documents and translations across HA and EC submission processes.

Skills

Regulatory submissions

Global coordination

Stakeholder communication

Regulatory strategy

Education

B.S./B.Sc in Pharmacy or Life Sciences

Tools

CTIS

Veeva

Job description

ICON Strategic Solutions is seeking a Regulatory Submission Manager to lead regulatory submissions for CTAs globally. The role sits in the Regulatory Affairs team and acts as regional representative within study teams.

You will manage translation coordination, core document gathering, and cross-functional collaboration with sponsors, SSU, and study management to ensure timely, compliant submissions.