Remote Clinical Start-Up Specialist (Regulatory)

Precision Medicine Group (New York, United States); Województwo mazowieckie; On-site; PLN 120,000 - 180,000; Full time

Job summary

Precision Medicine Group is seeking a Start Up Specialist for an on-site role in Poland. You will prepare CTAs and submission dossiers, interact with authorities, and support site activation across multiple markets.

Key requirements include Hungarian and English fluency, plus demonstrated Start Up or regulatory experience in CRO/pharma settings. Collaboration with cross-functional teams and timely regulatory submissions are essential.

Qualifications

• Bachelor's degree in life sciences or related field (ideally scientific/healthcare).
• Experience as Regulatory or Start Up specialist in CRO/pharma industry or equivalent.
• Must be fluent in Hungarian and English; strong communication and organizational skills.

Responsibilities

• Prepare Clinical Trial Applications and submission dossiers for authorities and ethics committees.
• Interact with Competent Authorities and Ethics Committees for study purposes.
• Maintain project plans, trackers and regulatory intelligence tools.
• Coordinate translations of documents and support site start-up plans.

Skills

Communication skills

Organizational skills

MS Office proficiency

Education

Bachelor's degree in life sciences or related field

RN or equivalent

Advanced life sciences degree / RAC / Regulatory Science

Tools

MS Excel

MS Word

Email systems

Job description

Precision Medicine Group is seeking a Start Up Specialist for an on-site role in Poland. You will prepare CTAs and submission dossiers, interact with authorities, and support site activation across multiple markets.

Key requirements include Hungarian and English fluency, plus demonstrated Start Up or regulatory experience in CRO/pharma settings. Collaboration with cross-functional teams and timely regulatory submissions are essential.