Regulatory and Site Start Up Specialist

The role

The Regulatory and Site Start Up Specialist manages regulatory and site start-up activities. This includes clinical trial submissions to Competent Authorities and IRB/Ethics Committees, document collection, and supporting site contract negotiations.

What you will do

• Deliver site activation readiness within assigned country/sites.
• Prepare Clinical Trial Application Forms and submission dossiers for CA, EC, and local bodies.
• Interact with CA/EC and handle responses.
• Provide regular updates on CA and EC submissions to leads and project teams.
• Maintain project plans, trackers, and regulatory intelligence tools.
• Prepare and support development of study specific start-up plans and essential document review criteria.
• Partner with site CRAs to ensure alignment and site collaboration.
• Prepare, review, and manage collection of essential documents for site activation.
• Customize country/site specific Patient Information Sheets and Informed Consent Forms.
• Facilitate translation and coordination of documents for submission.

Required qualifications

• Bachelor's degree in life sciences or related field, or Registered Nurse (RN) or equivalent combination of education, training, and experience.
• 1 year or more as a Regulatory or SU specialist (or comparable role) 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.
• Fluency in English and the local language of the country where the position is based.

Nice to have

• Relevant regulatory and site start-up experience for the particular country.
• 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 CRO that integrates clinical trial execution with scientific knowledge, laboratory expertise, and advanced data sciences. They focus on Oncology and Rare Disease.