Spain-Based Regulatory & Start-Up Specialist (Contracts & Budgeting)

Precision for Medicine; Spain (TX); Remote; EUR 45,000 - 75,000; Full time

Job summary

Precision for Medicine in Spain is seeking a Regulatory and Start Up Specialist to lead site activation, regulatory submissions, and country-specific documentation with a focus on timely approvals and inspection readiness. You will partner with Regulatory, Start Up, Clinical Operations and Site Contracts teams to ensure compliant, cost-efficient start-up processes.

The ideal candidate has contracts and budgeting negotiation experience for Spain, is fluent in English and Portuguese, and has prior

Qualifications

• Bachelor's degree in life sciences or related field, RN or equivalent.
• Pharmacy qualification is highly beneficial.
• Experience with regulatory submissions and contracts/budgets.
• Fluent in English and Portuguese.

Responsibilities

• Lead site activation readiness and regulatory submissions within Spain.
• Prepare Clinical Trial Application forms and submission dossiers.
• Interact with CA/EC and manage responses.
• Maintain regulatory trackers and start-up plans.
• Coordinate translations of documents and liaise with cross-functional teams.
• Support budget negotiations and site contract management.

Skills

Regulatory submissions

Contracts budgeting

Start-up regulatory

English

Portuguese

Contract negotiations

Education

Bachelor's in life sciences

Registered Nurse (RN)

Pharmacist qualification

Advanced degree in regulatory science

Job description

Precision for Medicine in Spain is seeking a Regulatory and Start Up Specialist to lead site activation, regulatory submissions, and country-specific documentation with a focus on timely approvals and inspection readiness. You will partner with Regulatory, Start Up, Clinical Operations and Site Contracts teams to ensure compliant, cost-efficient start-up processes.

The ideal candidate has contracts and budgeting negotiation experience for Spain, is fluent in English and Portuguese, and has prior