Senior Regulatory Analyst - NIS/RWE

Senior Regulatory Analyst – Non‑Interventional Studies (NIS) Oracle Life Sciences empowers pharmaceutical, biotechnology, medical device companies, and clinical research organizations to bring therapies to market faster and more efficiently, accelerating innovation and improving health outcomes worldwide. With ongoing ground‑breaking developments in Oncology and Rare Disease and an increased focus on targeted medicine, Oracle Life Sciences is seeking an accomplished Senior Regulatory Analyst specializing in Non‑Interventional Studies. This leadership opportunity involves coordinating and driving complex international regulatory and ethics submissions for clinical research, directly impacting the advancement of healthcare innovations worldwide, including major projects in international Real‑World Evidence (RWE) such as direct‑to‑patients and secondary data studies. Responsibilities Lead the preparation and submission of regulatory documents for Competent Authorities and Ethics Committees in the EU and other applicable regions. Ensure all regulatory submissions and clinical documentation comply with global and regional regulations including EMA, FDA, ICH GCP, EU MDR, and data privacy laws. Monitor and interpret evolving global and European regulatory frameworks, identifying changes that impact study operations and ensuring timely adaptation. Identify, assess, and mitigate risks related to regulatory submissions, avoiding approval delays. Serve as a subject matter expert and primary contact for Competent Authorities, Ethics Committees, clients, vendors, and internal teams, supporting studies both in the EU and, when required, in other international regions. Support feasibility assessments and business development with regulatory insights for various geographic markets. Enhance internal regulatory processes, documentation standards, and best practices to respond to evolving compliance needs. Required Experience and Qualifications Doctor of Pharmacy (PharmD) or Master’s Degree (or equivalent) in Life Sciences or a related healthcare discipline. Minimum 5 years’ experience in regulatory affairs for clinical studies, with strong EU experience and, ideally, exposure to global regulatory environments (e.g., North America, APAC, Latin America). In‑depth knowledge of EU regulatory requirements for NIS and RWE studies (e.g., direct‑to‑patients and secondary data studies), including ICH‑GCP and UK/EU GDPR, with a demonstrable understanding of requirements in other major global regions being a strong asset. Strong experience submitting to and liaising with Competent Authorities and Ethics Committees in multiple jurisdictions, mainly in Belgium and Switzerland, eventually Germany and Italy. Prior experience with medical device clinical investigations conducted under EU MDR and ISO 14155 compliance considered an asset. Full professional proficiency in English; other language skills are an advantage. Highly organized, detail‑oriented, able to work independently and in cross‑functional international teams. Excellent communication, analytical, and stakeholder management abilities. Career Level: IC3 Benefits Oracle offers competitive benefits including flexible medical, life insurance, and retirement options, and encourages employees to give back through volunteer programs. Oracle is an Equal Employment Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability, and protected veteran status, or any other characteristic protected by law. Oracle will consider for employment qualified applicants with arrest and conviction records pursuant to applicable law. #J-18808-Ljbffr Oracle