Regulatory and Start Up Specialist

Precision for Medicine is a Clinical Research Organization that enables the science of precision medicine through novel clinical trial designs, operational and medical expertise, advanced biomarker and data analytics solutions, and a deep passion for rare diseases and oncology. In addition, we work across other therapeutic areas. Regulatory and Start Up Specialist As our company continues to grow, we are seeking a Regulatory and Start Up Specialist to join our expanding team. Essential Functions Responsible for delivery, in terms of timeliness and quality, of site activation readiness within the assigned country/site and foreseeing and mitigating any risks. Preparation of Clinical Trial Application Forms and submission dossiers (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. 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, and to the Project Manager and Project Team. Maintenance of project plans, project trackers and regulatory intelligence tools, keeping Regulatory Leadership informed. Preparation and support 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 integration. Review and manage the collection of essential documents required for site activation/IMP release. Customize country/site specific Patient Information Sheet and Informed Consent Form. Facilitate the translation and coordination of translations for documents. Maintain communication with other key functions (Feasibility, Clinical Operations, Project Management, Regulatory, Site Contracts Management) on project status and deliverables. Act as SME for collection and maintenance of site‑level critical path data points (Competent Authority, local IRB/EC timelines, site contracts and budget negotiation requirements) to secure on‑time site activation. Participate/support negotiation of study budgets and execution of investigator contracts under direction of Site Contract Management. Participate/support feasibility group in site outreach to assess potential investigator interest. Keep updated knowledge of local clinical trial laws and regulations, disseminating this knowledge within Precision for Medicine. Maintain audit/inspection readiness at all times and file documents per TMF plan or study‑specific plans. Support the clinical team in performing pre‑study site visits. Minimum Required 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. Qualification in Pharmacy or work experience as a Pharmacist is highly beneficial. 1 year or more as a Regulatory or Start‑Up specialist (or comparable role) in a CRO or pharmaceutical/biotech industry, or equivalent experience and/or demonstrated competencies. Other Required Strong communication and organizational skills. Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail. Fluency in English. Preferred Relevant regulatory and site start‑up experience (feasibility, contract negotiations, CA/EC/IRB submissions). 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, or Masters in Regulatory Science. We invite you to learn more about our growing organization dedicated to researching groundbreaking cancer therapies. Employees are encouraged to contribute ideas that are valued and nurtured, impacting positive change for the company. Any data provided as part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice. Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or other characteristics protected by law. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process, please contact Precision Medicine Group at We have received reports that some individuals or organizations may present themselves as potential employers. These offers are not associated with our company and may be fraudulent. We will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process. #J-18808-Ljbffr