Remote Regulatory & Start-Up Specialist

Precision for Medicine; United States; Remote; USD 90,000 - 130,000; Full time

Job summary

Precision for Medicine is seeking a Regulatory and Start Up Specialist to join our growing team. You will deliver timely site activation readiness, prepare Clinical Trial Applications, and manage CA/EC submissions across countries.

The role requires Hungarian and English fluency, strong communication skills, and experience in CRO/pharma environments. You will maintain regulatory trackers, assist with start-up plans, and coordinate translations of essential documents, ensuring compliance with

Qualifications

• Bachelor’s degree in life sciences or RN (or equivalent).
• Pharmacist qualification is highly beneficial.
• Regulatory or Start Up experience in CRO/pharma industry.
• Fluency in Hungarian is required.
• Fluency in English is required.
• Strong communication and organizational skills.
• Experience with computerized information systems.
• Ability to prioritize workload to meet deadlines.
• Advanced degree or RAC certification preferred.

Responsibilities

• Manage site activation readiness within the country/sites and mitigate risks.
• Prepare Clinical Trial Application forms and submission dossiers for authorities.
• Interact with CA/EC and respond to submissions.
• Provide updates to Start Up Lead/Regulatory Lead and Project Team.
• Maintain project plans, trackers and regulatory tools.
• Support start-up plans, IMP release requirements and essential documents.
• Coordinate with site CRA to align communication and activation.
• Coordinate collection and translation of essential documents for activation.
• Communicate status with cross-functional teams on deliverables.
• Maintain knowledge of local trial laws to ensure compliance.

Skills

Fluency in English

Fluency in Hungarian

Strong communication

Organizational skills

Education

Bachelor’s degree in life sciences or RN

Pharmacist qualification

Advanced degree in life sciences / RAC

Job description

Precision for Medicine is seeking a Regulatory and Start Up Specialist to join our growing team. You will deliver timely site activation readiness, prepare Clinical Trial Applications, and manage CA/EC submissions across countries.

The role requires Hungarian and English fluency, strong communication skills, and experience in CRO/pharma environments. You will maintain regulatory trackers, assist with start-up plans, and coordinate translations of essential documents, ensuring compliance with