Regulatory and Start Up Specialist; Portuguese speaker); Fully Remote

• Prepare and submit Clinical Trial Application forms and dossiers to Competent Authorities, Ethics Committees, and other local bodies, ensuring all necessary approvals.
• Act as a Subject Matter Expert for site activation, including critical path data, budgets, and contract negotiations.
• Provide regular updates to Start Up leads and project teams, maintain regulatory intelligence tools, and support audits and inspections.

Qualifications:

• Bachelor's degree in life sciences or related field, or RN, with experience in regulatory and start-up roles in CRO/pharma.
• Strong negotiation skills for contracts and budgets, and fluency in English and Portuguese.
• Excellent communication, organizational skills, and proficiency in computerized systems.
• This is a remote position based in Spain, collaborating with global teams.
• You will work closely with Clinical Operations, Project Management, and other key functions.

About the Team:

• Precision for Medicine is committed to advancing precision medicine and offers a dynamic, collaborative environment.
• They are an Equal Opportunity Employer and support professional growth.

Precision for Medicine is a global Clinical Research Organization specializing in precision medicine, combining novel trial designs, biomarkers, and data analytics. They focus strongly on rare diseases and oncology, and their culture emphasizes innovation, collaboration, and regulatory excellence.