Regulatory and Start Up Specialist (Portuguese speaker)

The role

The Regulatory and Start Up Specialist manages site activation readiness and regulatory submissions within an assigned country. This role involves preparing submission dossiers, negotiating contracts and budgets, and interacting with Competent Authorities and Ethics Committees.

What you will do

• Deliver site activation readiness within assigned country and sites.
• Prepare Clinical Trial Application Forms and submission dossiers for Competent Authorities and Ethics Committees.
• Interact with CA/EC and handle responses.
• Provide regular updates on submissions to the Start Up Lead, Regulatory Lead, and Project Manager.
• Maintain project plans, trackers, and regulatory intelligence tools.
• Prepare and support study specific start-up plans and IMP release requirements.
• Partner with site CRA to ensure communication alignment.
• Review and manage collection of essential documents for site activation.
• Customize Patient Information Sheets and Informed Consent Forms.
• Facilitate translation and coordination of documents.

Required qualifications

• Bachelor’s degree in life sciences or related field, or Registered Nurse (RN) or equivalent combination of education, training, and experience.
• Demonstrated experience in contracts and budgeting negotiation.
• Experience related to regulatory submissions.
• Fluency in English and Portuguese.
• Previous experience working as a Regulatory or Start Up specialist in either a CRO or pharmaceutical/ biotech industry or equivalent.
• Strong communication and organizational skills.
• Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail.

Nice to have

• Qualification in Pharmacy/ work experience as a Pharmacist
• Relevant regulatory and site start-up (feasibility, contract negotiations, CA/ EC/ IRB submissions) experience.
• Experience using milestone tracking tools/systems.
• Ability to prioritize workload to meet deadlines
• Advanced degree in medical or life sciences (MD, PhD, PharmD)
• RAC certification
• Masters in Regulatory Science

About the company

Precision for Medicine is a global Clinical Research Organization with uniquely integrated offering which enables the science of precision medicine. They work across therapeutic areas including rare diseases and oncology.