Senior Regulatory Analyst - NIS/RWE
Ll Oefentherapie, Sauk Trail Beach, WI, United States
Does this position require a security clearance? No
Years 3 to 5+ years
Additional Info Visa / work permit sponsorship is not available for this position
Applicants are required to read, write, and speak the following languages English
Job Description
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 worldwide,
including 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, you’ll 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.
Responsibilities
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 Master’s 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.
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 veterans’ status, or any other characteristic protected by law. Oracle will consider for employment qualified applicants with arrest and conviction records pursuant to applicable law.
We’re committed to including people with disabilities at all stages of the employment process. If you require accessibility assistance or accommodation for a disability at any point, let us know by emailing accommodation-request_mb@oracle.com or by calling 1-888-404-2494 in the United States.
#J-18808-Ljbffr
Years 3 to 5+ years
Additional Info Visa / work permit sponsorship is not available for this position
Applicants are required to read, write, and speak the following languages English
Job Description
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 worldwide,
including 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, you’ll 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.
Responsibilities
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 Master’s 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.
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 veterans’ status, or any other characteristic protected by law. Oracle will consider for employment qualified applicants with arrest and conviction records pursuant to applicable law.
We’re committed to including people with disabilities at all stages of the employment process. If you require accessibility assistance or accommodation for a disability at any point, let us know by emailing accommodation-request_mb@oracle.com or by calling 1-888-404-2494 in the United States.
#J-18808-Ljbffr