Regulatory & Start-Up Specialist — Portuguese Speaker

Precision for Medicine

Madrid

On-site

EUR 50,000 - 70,000

Full time

14 days+

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Job summary

Precision for Medicine in Madrid is seeking a Regulatory and Start Up Specialist (Portuguese speaker) for a full-time, on-site role. You will lead site activation activities, manage regulatory submissions, and coordinate with CA/EC and ethics committees to obtain approvals in Spain.

The ideal candidate has a life sciences degree, experience in contracts and budgeting for Spain, and fluency in English and Portuguese.

Qualifications

Bachelor's degree in life sciences or related field, or RN or equivalent combination of education, training, and experience.
Pharmacy degree or pharmacist experience would be highly beneficial.
Experience in contracts and budgeting negotiation, on top of regulatory submissions.
Fluency in English and Portuguese.

Responsibilities

Deliver site activation readiness on time and with quality for Spain/assigned sites.
Prepare Clinical Trial Application forms and submission dossiers for authorities and ethics committees.
Interact with CA/EC for study purposes and responses.
Provide regular updates to Start Up Lead/Regulatory Lead and Project Manager.
Maintain project plans, trackers and regulatory intelligence tools.
Coordinate translations and document review for start-up documents.
Collaborate with Site Contracts management and cross-functional teams.