Global Regulatory & Startup Specialist - Growth & Impact

Clarenta; Polska; On-site; PLN 140,000 - 200,000; Full time

Job summary

Clarenta, a European full-service Contract Research Organization, seeks a Regulatory & Startup Specialist to lead regulatory submissions and governance for clinical trials. You will collaborate with cross-functional teams to ensure compliance and timely delivery across international markets.

The role requires a life sciences degree, 3+ years in regulatory affairs and startup activities, and strong English communication. Opportunity for growth within a dynamic, international regulatory team.

Qualifications

• Bachelor’s degree in Life Sciences (Biology, Pharmacy, Chemistry, or related fields).
• At least 3 years of proven experience in regulatory affairs and clinical trial startup.
• Solid understanding of ICH-GCP and local regulatory frameworks.
• Familiarity with end-to-end clinical trial operations.
• Professional fluency in English (written & spoken).
• Proficiency in MS Office (Word, Excel, PowerPoint).

Responsibilities

• Prepare, review, and manage submissions to Ethics Committees (ECs) and Regulatory Authorities (RAs).
• Review Investigator’s Brochure and support development of patient-facing documents (ICFs, patient materials).
• Track, evaluate, and resolve regulatory challenges, ensuring timelines.
• Maintain communication with ECs, RAs, and site stakeholders.
• Ensure accuracy and audit-readiness of regulatory files through cross-functional collaboration.
• Keep regulatory trackers and internal documentation updated and audit-ready.
• Support implementation of new processes and regulatory updates.
• Guide team members through knowledge-sharing and internal training.

Skills

Regulatory affairs

Clinical trial startup

ICH-GCP

Analytical thinking

MS Office

Education

Bachelor’s degree in Life Sciences

Tools

MS Office

Job description

Clarenta, a European full-service Contract Research Organization, seeks a Regulatory & Startup Specialist to lead regulatory submissions and governance for clinical trials. You will collaborate with cross-functional teams to ensure compliance and timely delivery across international markets.

The role requires a life sciences degree, 3+ years in regulatory affairs and startup activities, and strong English communication. Opportunity for growth within a dynamic, international regulatory team.