Lead RASSU Regulatory Start-Up Specialist

CTI Clinical Trial and Consulting Services; Poland; Ibrido; PLN 250.000 - 320.000; Tempo pieno

Vantaggi offerti da questo lavoro

Hybrid work opportunities

Descrizione del lavoro

CTI Clinical Trial and Consulting Services seeks an experienced Regulatory Start-Up professional to support the RASSU department. The role involves advising project teams on regulatory requirements for clinical studies and ensuring compliance across countries and sites.

You will review and adapt study documents, manage regulatory submissions, and interact with sponsors, sites, and regulatory bodies. A strong background in pharma/CRO regulation and English fluency is required.

Competenze

• Needs to be fluent in spoken and written English.
• Minimum 8–10 years of pharmaceutical or CRO Regulatory experience.
• Strong ability to review, adapt and compile regulatory documents per country/site requirements.

Mansioni

• Assist/advise project teams on regulatory requirements for clinical studies.
• Perform compliance assessments per country requirements and notify managers of findings.
• Review and adapt study documents for country/site requirements.
• Oversee submissions to IRB/IEC/CA and other regulatory bodies as agreed with Sponsor.
• Compile regulatory documentation per CTI/Sponsor SOPs and perform QC reviews.

Conoscenze

English fluency

Regulatory experience

Project coordination

Formazione

Associate’s or bachelor’s degree in life sciences

Descrizione del lavoro

CTI Clinical Trial and Consulting Services seeks an experienced Regulatory Start-Up professional to support the RASSU department. The role involves advising project teams on regulatory requirements for clinical studies and ensuring compliance across countries and sites.

You will review and adapt study documents, manage regulatory submissions, and interact with sponsors, sites, and regulatory bodies. A strong background in pharma/CRO regulation and English fluency is required.