Associate Director, Regulatory Affairs – Oncology
Sumitomo Pharma America, Inc.
Director, US Regulatory Intelligence – Policy Lead
Daiichi Sankyo US
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇺🇸 United States
Visit company websiteSalary
💰 $189,520 - $284,280 per year
Job Level
Senior
About the role
- Lead US regulatory intelligence acquisition, analysis, communication, and knowledge management
- Interpret and apply US regulatory intelligence to inform strategic decisions
- Manage and improve the GRIP CoE Hub
- Develop and implement an assigned project portfolio
- Lead DS regulatory policy and advocacy activities for assigned topics
Requirements
- Bachelor's degree in medicine, life sciences, health, or related field required
- 7 or more years' experience in biopharma Regulatory Affairs
- At least 3 years developing regulatory strategies
- 4 or more years leading Regulatory Intelligence & Policy activities in the U.S.
- Strong relationships across FDA and PhRMA highly desirable
- 1 or more years experience working with international teams
- 1 or more years experience of working with oncology drugs, Biologics/ADCs Companion diagnostics preferred
Benefits
- Exceptional working environment
- Training and tools provided
- Open communication
- Emphasis on results
- Spirit of personal accountability
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
regulatory intelligenceregulatory strategiesregulatory policyproject managementbiopharmaoncology drugsbiologicsADCscompanion diagnostics
Soft skills
leadershipcommunicationrelationship managementstrategic decision-makingcollaboration
