Regulatory and Start Up Specialist

The role

The Regulatory and Start Up Specialist manages site activation readiness and regulatory submissions. This role covers regulatory submissions and site contract and budget negotiation in Germany, Austria, and Switzerland.

What you will do

• Deliver site activation readiness within assigned countries 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 alignment in communication.
• Review and manage collection of essential documents for site activation.
• Customize country and site specific Patient Information Sheets and Informed Consent Forms.
• 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 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.
• Fluency in English and German.

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 Medicine Group is a global Clinical Research Organization with integrated offerings for precision medicine. They combine clinical trial designs, operational and medical experts, and data analytics solutions.