Regulatory and Start Up Specialist

This is a fully remote position, open to applicants in United Kingdom.

📋 Description

• Ensure timely and high-quality readiness for site activation across designated countries and sites while proactively identifying and addressing risks.

• Prepare Clinical Trial Application forms and submission packages for Competent Authorities, Ethics Committees, and other relevant local entities.

• Engage with Competent Authorities and Ethics Committees, managing all correspondence effectively.

• Provide consistent submission updates to Start Up Leads, Regulatory Leads, Project Managers, and project teams.

• Maintain comprehensive project plans, trackers, and tools for regulatory intelligence.

• Assist in developing study-specific start-up strategies, requirements for IMP release, and essential document review standards.

• Collaborate with assigned site CRAs to ensure effective communication and facilitate site activation.

• Review and oversee essential documentation necessary for site activation and IMP release.

• Tailor country/site-specific Patient Information Sheets and Informed Consent Forms.

• Coordinate the translation of documents.

• Liaise with Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts Management teams regarding status updates and deliverables.

• Maintain critical path data at the site level for timelines associated with Competent Authorities, IRB/Ethics Committee reviews, site contracts, budget negotiations, and other evaluations.

• Assist in negotiations related to study budgets and the execution of investigator contracts.

• Support feasibility initiatives and site outreach efforts.

• Stay informed about local clinical trial regulations and share insights within Precision for Medicine.

• Ensure readiness for audits and inspections, filing documents in accordance with TMF and study-specific protocols.

• Support clinical teams in conducting Pre-Study Site Visits.

⛳️ Requirements

• Bachelor’s degree in life sciences or a related field, or Registered Nurse (RN), or a comparable combination of education, training, and experience.

• A minimum of 2 years of relevant professional experience.

• Prior experience as a Regulatory and Start Up Specialist or Site Contracts Specialist within a CRO or the pharmaceutical/biotech sector, or equivalent relevant experience and/or demonstrated competencies.

• Familiarity with regulatory submissions.

• Proficient in using computerized information systems, electronic spreadsheets, word processing, and email platforms.

• Fluent in English.

• Relevant experience in regulatory and site start-up processes, including feasibility studies, contract negotiations, and CA/EC/IRB submissions.

• Experience in site contract and budget negotiation is a significant advantage.

• Proficient in using milestone tracking tools/systems.

• An advanced degree in medical or life sciences, RAC certification, or a Master’s in Regulatory Science is preferred.

• Must possess legal authorization to work in the employment country without employer sponsorship.

🏝️ Benefits

• Full-time regular employment.

• Flexible remote work options.

• Commitment to equal opportunity employment.

• Reasonable accommodations available throughout the application process.