Regulatory & Startup Specialist

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 is a European full-service Contract Research Organization, with a dedicated Phase I Unit based in Sofia, Bulgaria. We provide comprehensive clinical research services and work with pharmaceutical and biotechnology companies across international markets.

We are looking for a dedicated Regulatory & Startup Specialist to join our expert regulatory team. This role is perfect for a proactive, detail-driven professional seeking to contribute directly to the successful launch and governance of clinical trials.

Your Mission

• Prepare, review, and manage submissions to Ethics Committees (ECs) and Regulatory Authorities (RAs), ensuring full compliance with national regulations and internal SOPs.


• Review Investigator’s Brochure and support the development of patient-facing documents (ICFs, patient materials).


• Track, evaluate, and resolve regulatory challenges, ensuring adherence to evolving standards and timelines.


• Maintain continuous communication and positive relationships with ECs, RAs, and site stakeholders.


• Ensure accuracy, compliance, and completeness of regulatory files through close cross-functional collaboration.


• Keep regulatory trackers and internal documentation systems updated and audit-ready.


• Support implementation of new processes, regulatory updates, and improvement initiatives driven by the Global Head of Regulatory & Safety.


• Guide team members through knowledge-sharing and participation in internal training.

What you bring

You are a strong communicator, collaborator, and regulatory problem-solver with:

• Bachelor’s degree or above 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


• Excellent organization, analytical thinking, and adaptability to fast timelines


• Professional fluency in English (written & spoken)


• Proficiency in MS Office (Word, Excel, PowerPoint)

Why Join us?

At Clarenta, your expertise matters - and so does your growth.

• Work alongside experienced, supportive, and highly motivated colleagues


• Join a diverse, international, and collaborative work culture


• Gain exposure to complex studies across multiple therapeutic areas, including early-phase programs


• Access development opportunities and clearly defined career advancement


• Competitive compensation and continuous training support

Ready to Advance Your Regulatory Career?

Be part of a dynamic team shaping the future of clinical research.