Regulatory Submissions Lead, Clinical Trials

IQVIA LLC

Warszawa

On-site

PLN 106,000 - 374,000

Full time

14 days+

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Job summary

IQVIA LLC is seeking a seasoned professional to coordinate operational and strategic aspects for Clinical Trial Submissions in Warsaw, Poland. The role covers strategy development, submission planning, and regulatory approval processes, ensuring timely and successful trial submissions.

You will lead discussions with cross-functional teams, manage CTIS submissions, and perform quality control on submission packages.

Qualifications

3 to 5 years of experience preparing and managing Clinical Trial Regulation (CTR) submissions.
Strong knowledge of Good Clinical Practice (GCP), ICH guidelines, and applicable regulatory requirements.
Experience in regulatory affairs and clinical trial submissions.
Proven project management skills, coordinating multiple activities and meeting deadlines in a fast-paced environment.

Responsibilities

Lead the clinical trial submission process from strategy development through regulatory approval.
Develop and coordinate submission strategies to ensure timely and successful trial submissions.
Facilitate discussions with cross-functional stakeholders and drive alignment on CTR submission approaches.
Coordinate and manage submissions through the CTIS portal.
Perform quality control reviews of CTIS applications and submission packages prior to submission.
Oversee financial planning, budgeting, and tracking activities related to clinical trial submissions.