Regulatory and Start Up Specialist

Job Description

As a Regulatory and Start Up Specialist, your main responsibility is to ensure the prompt and high-quality delivery of site activation readiness within assigned countries and sites, proactively identifying and mitigating potential risks. Key duties include: 1. Preparing Clinical Trial Application Forms and submission dossiers (initial submissions, amendments, and notifications) for Competent Authorities, Ethics Committees, and other local bodies. This must be done according to local requirements and within specified timelines to secure necessary authorizations/approvals for clinical trial conduct, aligning with international and local regulations, company SOPs, and ICH-GCP principles. 2. Interacting with regulatory bodies and ethics committees for study-related purposes and managing responses. 3. Providing regular updates on regulatory submissions to the Start Up Lead, Regulatory Lead, Project Manager, and Project Team. 4. Maintaining project plans, trackers, and regulatory intelligence tools pertinent to your responsibilities. 5. Supporting the development of study-specific start-up plans, IMP release requirements, and essential document review criteria. 6. Partnering with site CRAs to ensure aligned communication and secure site review, managing the collection of essential documents for site activation/IMP release. 7. Customizing country/site-specific Patient Information Sheets and Informed Consent Forms. 8. Coordinating and facilitating document translations. 9. Maintaining communication with key functions involved in country start-up, including Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts management, to update on project status and deliverables. 10. Acting as a Subject Matter Expert (SME) for collecting and maintaining critical path data points for Site Activation, including timelines for Competent Authorities, local IRB/Ethics Committees, site contracts, and budget negotiation requirements. 11. Participating in the negotiation of study budgets and execution of investigator contracts under the guidance of the Site Contract Management department. 12. Supporting feasibility assessments by reaching out to potential investigators to gauge interest in potential studies. 13. Staying updated on local clinical trial laws and regulations, sharing knowledge within PFM to ensure clinical trials are conducted according to international and local regulations. 14. Maintaining audit/inspection readiness and filing documents as per the TMF plan. 15. Supporting the clinical team with Pre-Study Site Visits.

Qualifications

1. Bachelor’s degree in life sciences or a related field (preferably in a scientific or healthcare discipline), or Registered Nurse (RN) certification, or an equivalent combination of education, training, and experience. 2. A qualification in Pharmacy or work experience as a Pharmacist is highly desirable. 3. Demonstrated experience in contracts and budget negotiation. 4. Experience working as a Regulatory or Start Up specialist in a CRO or pharmaceutical/biotech industry, or equivalent relevant experience and demonstrated competencies is desirable. 5. Strong communication and organizational skills are essential. 6. Proficiency in using computerized information systems, electronic spreadsheets, word processing, and electronic mail is required. 7. Fluency in English is required.

Benefits

- Competitive salary - Health insurance - Professional development opportunities - Flexible work arrangements