Director, US Regulatory Intelligence – Policy Lead
Daiichi Sankyo US
Associate Director, Regulatory Affairs – Oncology
Sumitomo Pharma America, Inc.
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇺🇸 United States
Visit company websiteSalary
💰 $156,000 - $195,000 per year
Job Level
Senior
About the role
- manage regional (United States, European and/or ROW) regulatory activities as part of a Global Regulatory Team (GRT)
- leads regulatory activities for assigned project(s) in line with the global registration strategy of the product
- develops regulatory strategy and provides regulatory input as appropriate
- ensures compliance with global regulatory requirements and coordination of regulatory compliance activities at a global level
- provides updates to the Global Regulatory Team, project teams, and governance boards as needed
- maintains professional working relationships with colleagues, fostering collaboration, and idea sharing
- reviews nonclinical, clinical and CMC documentation and contributes to content as needed
Requirements
- Bachelor’s degree in a related field required, preferably in a scientific discipline
- At least 7 years of experience, prior biopharmaceutical or pharmaceutical industry experience; Ideally with a minimum of 4 years focused in regulatory affairs
- Oncology product development experience preferred
- Experience contributing to electronic regulatory submissions and working with regulatory templates
- Understanding of EU Clinical Trial Regulation and ROW country regulatory requirements related to clinical trials
Benefits
- merit-based salary increases
- short incentive plan participation
- eligibility for our 401(k) plan
- medical, dental, vision, life and disability insurances
- flexible paid time off
- 11 paid holidays
- additional time off for a shut-down period during the last week of December
- 80 hours of paid sick time upon hire and each year thereafter
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
regulatory strategy developmentregulatory complianceelectronic regulatory submissionsclinical documentation reviewCMC documentation reviewregulatory templatesOncology product developmentbiopharmaceutical industry experiencepharmaceutical industry experienceregulatory affairs
Soft skills
collaborationcommunicationrelationship managementidea sharingleadership
Certifications
Bachelor’s degree
