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 country/sites and mitigate risks.
• 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 essential document review criteria.
• Partner with site CRA to ensure alignment in communication.
• Review and manage collection of essential documents for site activation and IMP release.
• Customize country/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 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

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.