Senior Regulatory Analyst - NIS/RWE
Oracle
Job Overview
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Job Description
About the Role
Oracle Life Sciences empowers pharmaceutical, biotechnology, and clinical research organizations to bring therapies to market faster. The Senior Regulatory Analyst - NIS/RWE role is a unique leadership opportunity to coordinate complex international regulatory and ethics submissions, directly impacting healthcare innovations worldwide.
Key Responsibilities
- Lead preparation and submission of regulatory documents to Competent Authorities and Ethics Committees.
- Ensure compliance with global and regional regulations including EMA, FDA, ICH GCP, EU MDR, and data privacy laws.
- Monitor evolving regulatory frameworks to drive timely adaptations.
- Act as the primary contact for regulatory bodies, clients, vendors, and internal teams.
- Support feasibility assessments and business development with regulatory insights.
- Enhance internal processes and documentation standards in response to compliance needs.
Required Experience & Qualifications
Applicants should hold a Doctor of Pharmacy (PharmD) or Master’s Degree in Life Sciences or a related field and have a minimum of 5 years’ experience in regulatory affairs, with strong EU and global regulatory exposure, particularly in NIS and RWE studies. Experience with submissions to multiple jurisdictions, especially in Belgium, Switzerland, Germany, and Italy, is essential. Proficiency in English is required.
About Oracle Life Sciences
Oracle Life Sciences brings together data, infrastructure, and expertise to drive industry innovations and life-saving care. The company is committed to inclusivity, flexible benefits, and community involvement, ensuring a supportive environment for all employees.
Key skills/competency
- Regulatory
- NIS
- RWE
- Compliance
- International
- Submission
- Ethics
- Clinical
- EU
- Risk
How to Get Hired at Oracle
- Research Oracle's culture: Study mission, values, and recent press releases.
- Tailor your resume: Highlight regulatory and compliance experiences.
- Emphasize EU expertise: Showcase global regulatory submission skills.
- Prepare for interviews: Practice scenario-based regulatory questions.
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