Regulatory and Start Up Specialist

The role

The Regulatory and Start Up Specialist is responsible for site activation readiness within assigned countries or sites. This role involves preparing clinical trial application forms and submission dossiers for Competent Authorities and Ethics Committees.

What you will do

• Deliver site activation readiness within assigned country or 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 or support development of study specific start-up plans and IMP release requirements.
• Partner with assigned site CRA to ensure alignment in communication.
• Review and manage collection of essential documents for site activation and IMP release.
• Customize country or site specific Patient Information Sheet and Informed Consent Form.
• Facilitate the translation and coordination of translations for documents.

Required qualifications

• Bachelor’s degree in life sciences or related field, or Registered Nurse (RN) or equivalent combination of education, training, and experience.
• At least 2 years of relevant experience.
• Previous experience working as a Regulatory and Start Up Specialist or Site Contracts Specialists 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.

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 in site contract and budget negotiation
• 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

Before you apply

• Candidates must be legally authorized to work in the country of employment without employer sponsorship.

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 with a passion for rare diseases and oncology.