Senior Regulatory Analyst NISRWE

Oracle Life Sciences empowers pharmaceutical biotechnology medical device companies and clinical research organizations to bring therapies to market faster and more efficiently. We are helping organizations accelerate innovation and improve health outcomes for patients worldwide.

With ongoing and ground-breaking developments in Oncology and Rare Disease an increased focus on more scientific targeted medicine and continuous integration of technology into development and delivery of medicine there has never been a more exciting time to join us!

Thanks to our ongoing global growth Oracle Life Sciences is seeking an accomplished Senior Regulatory Analyst specializing in Non-Interventional Studies (NIS). This is a unique leadership opportunity to coordinate and drive complex international regulatory and ethics submissions for clinical research directly impacting the advancement of healthcare innovations worldwideincluding major projects in international Real-World Evidence (RWE) (including direct-to-patients and secondary data studies).

You will join a collaborative team of regulatory professionals with expertise in steering multi-country submissions from project start-up to study close-out. Working in a fast-paced and engaged environment youll lead critical international submission activities across a variety of NIS and RWE study types provide strategic regulatory guidance and further your career as part of our growing global organization.

Working Environment: Hybrid minimum 1 day at the Paris Office (75008)

What you will do

• Lead the preparation and submission of regulatory documents for Competent Authorities and Ethics Committees in the EU and other regions as applicable.
• Ensure all regulatory submissions and clinical documentation comply with global and regional regulations including EMA FDA and relevant regional authorities ICH GCP guidelines 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

• Doctor of Pharmacy (PharmD) or Masters Degree (or equivalent) in Life Sciences or a related healthcare discipline.
• Minimum 5 years experience in regulatory affairs for clinical studies must include strong EU experience and ideally additional exposure to global regulatory environments (e.g. North America APAC Latin America).
• In-depth knowledge of EU regulatory requirements and processes for NIS and RWE studies (e.g. direct-to-patients and secondary data studies) including ICH-GCP UK/EU GDPR with a demonstrable understanding of requirements in other major global regions considered 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 will be 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