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 in designated countries/sites while identifying and mitigating potential risks.

• Prepare Clinical Trial Application forms and submission documentation for Competent Authorities, Ethics Committees, and other local organizations.

• Engage with Competent Authorities and Ethics Committees to manage communications and responses.

• Provide consistent updates on submissions to Start Up/Regulatory Leads and Project Managers/Project Teams.

• Maintain project plans, trackers, regulatory intelligence tools, and data related to site activation.

• Assist with study-specific start-up plans, IMP release requirements, and criteria for essential document reviews.

• Collaborate with site CRAs to ensure aligned communications and successful site activation.

• Review and manage necessary documents for site activation and IMP release.

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

• Oversee the translation of documents.

• Coordinate with teams in Feasibility, Clinical Operations, Project Management, Regulatory Affairs, and Site Contracts.

• Assist in site contract and budget negotiations, as well as the execution of investigator contracts.

• Support outreach efforts for feasibility sites and conduct Pre-Study Site Visits as needed.

• Stay informed about local clinical trial laws and regulations, sharing insights within PFM.

• Ensure audit/inspection preparedness and properly file documents in the applicable TMF.

⛳️ Requirements

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

• A minimum of 2 years of relevant experience.

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

• Excellent communication and organizational abilities.

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

• Fluency in English.

• Legally eligible to work in the country of employment without the need for employer sponsorship.

• Qualification in Pharmacy or experience as a Pharmacist is highly advantageous.

• Preferred experience in regulatory and site start-up processes.

• Experience in negotiating site contracts and budgets is preferred.

• Familiarity with milestone tracking tools/systems is preferred.

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

🏝️ Benefits

• Regular full-time employment.

• Remote work arrangement.

• Equal Opportunity Employer.

• Reasonable accommodations available for applicants with disabilities.