Regulatory and Start Up Specialist
Precision For Medicine
full-time
Posted on:
Location Type: Remote
Location: Spain
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Job Level
Tech Stack
About the role
- Responsible for delivery, in terms of timeliness and quality, of site activation readiness within the assigned country/sites and foreseeing and mitigating any risks.
- Preparation of Clinical Trial Application Forms as well as preparation of submission dossier (initial and amendments/notifications) for submission to Competent Authorities, Ethics Committees, and other applicable local bodies according to local requirements and within required timelines to obtain all necessary authorizations/approvals for the conduct of the Clinical Trial according to international and local/national applicable regulations, company SOPs and principles of ICH-GCP.
- Interaction with CA/EC for study purposes and handling responses to the CA/EC.
- Providing regular updates about CA and EC submissions to the Start Up Lead and/or Regulatory Lead assigned to the study and to Project Manager/Project Team.
- Maintenance of project plans, project trackers and regulatory intelligence tools as it pertains to assigned responsibilities and to keep Regulatory Leadership.
- Preparation/Support the development of study specific start-up plans, IMP release requirements and essential document review criteria.
- Partner with the assigned site CRA to ensure alignment in communication and secure site review and manage collection of essential documents required for site activation/IMP release.
- Customize country/site specific Patient Information Sheet and Informed Consent Form.
- Responsible for/facilitates the translation and co-ordination of translations for documents.
- Maintain communication with other key functions participating to country start up e.g., Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts management group on project specific status and deliverables.
- Act as SME for collection and maintenance of site level critical path to Site Activation data points, including but not limited to Competent Authority, local IRB/Ethics Committee (EC) timelines, site contracts and budget negotiation requirements for and other required reviews to secure on time site activation for the assigned sites in the country.
- When required, participate/support the negotiation of study budgets and the execution of investigator contracts under directions of Site Contract Management department/designee department.
- May participate/support feasibility group in site outreach to assess potential interest of investigators to a potential study.
- Keep an updated knowledge of the local clinical trial laws, regulations and help distributing their knowledge within PFM to ensure the conduct of Clinical Trials according to international and local/national applicable regulations.
- Maintain audit/inspection readiness at all times and file documents as per TMF plan and/or study specific plans in the relevant TMF.
- May support the clinical team performing Pre-Study Site Visits.
Requirements
- Bachelor’s degree in life sciences or related field (ideally in a scientific or healthcare discipline), or Registered Nurse (RN) or equivalent combination of education, training, and experience.
- A qualification in Pharmacy/ work experience as a Pharmacist would be highly beneficial.
- 1 year or more as a Regulatory or SU specialist (or comparable role) in either a CRO or pharmaceutical/biotech industry or equivalent, relevant experience and/or demonstrated competencies.
- Strong communication and organizational skills.
- Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail required.
- Fluency in English.
Benefits
- Health insurance
- Paid time off
- Professional development
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
Clinical Trial Application Formssubmission dossier preparationregulatory intelligence toolsstudy specific start-up plansIMP release requirementsessential document reviewaudit/inspection readinessTMF plan managementsite activation data managementbudget negotiation
Soft skills
communication skillsorganizational skills
Certifications
Bachelor’s degree in life sciencesRegistered Nurse (RN)qualification in Pharmacy