Spain Regulatory & Start-Up Specialist

precisionmedicinegroup; United States; Remote; USD 62,000 - 84,000; Full time

Job summary

Precision Medicine Group is seeking a Regulatory and Start Up Specialist based in Spain to lead site activation activities across assigned countries, ensuring timely regulatory submissions and approvals in line with ICH-GCP and local regulations.

The role requires contract and budget negotiations, strong communication, and cross-functional coordination with Clinical Operations, Regulatory, and Site Contracts. Fluency in English and Spanish is essential; Portuguese is a plus.

Qualifications

• Bachelor’s degree in life sciences or related field (ideally in a scientific or healthcare discipline), or RN or equivalent.
• A qualification in Pharmacy / work experience as a Pharmacist would be highly beneficial.
• Experience in contracts and budgeting negotiations.
• Previous regulatory/start-up experience in CRO or pharma industry.
• Fluency in English and Spanish; Portuguese would be a strong plus.

Responsibilities

• Delivery of site activation readiness within the assigned country/sites, ensuring timeliness and quality.
• Prepare Clinical Trial Applications and submission dossiers for authorities and ethics committees.
• Interact with CA/EC for study purposes and respond to inquiries.
• Maintain regulatory trackers, plans, and regulatory intelligence tools.
• Coordinate translations and essential document collection for activation.
• Negotiate study budgets and investigator contracts under Site Contract Management guidance.
• Foster cross-functional communication with Feasibility, Operations, Regulatory, and Contracts teams.

Skills

Regulatory knowledge

Contract negotiations

Budgeting

Communication skills

English fluency

Spanish fluency

Education

Bachelor’s degree in life sciences or related field

RN (Registered Nurse) or equivalent

Pharmacist qualification (beneficial)

Job description

Precision Medicine Group is seeking a Regulatory and Start Up Specialist based in Spain to lead site activation activities across assigned countries, ensuring timely regulatory submissions and approvals in line with ICH-GCP and local regulations.

The role requires contract and budget negotiations, strong communication, and cross-functional coordination with Clinical Operations, Regulatory, and Site Contracts. Fluency in English and Spanish is essential; Portuguese is a plus.