Associate Director, Global Regulatory Project Management – Oncology
Takeda
full-time
Posted on:
Location Type: Remote
Location: Remote • Massachusetts • 🇺🇸 United States
Visit company websiteSalary
💰 $153,600 - $241,340 per year
Job Level
Senior
About the role
- Partnering with the program Global Regulatory Lead (GRL) to co-lead Global Regulatory Team (GRT) meetings
- Ensure Global Product Team (GPT) regulatory goals are cascaded
- Proactively drive GRT and SWG project teams
- Develop and maintain integrated regulatory project plans
- Provide regulatory operational support activities for assigned programs
- Ensure out-sourced regulatory operational deliverables meet all timelines
- Prepare and deliver reports on major regulatory milestones
- Collaborate with the GRL in presenting operational strategies
Requirements
- Bachelors degree required
- Emphasis in Science preferred
- Advanced degree preferred
- Minimum of 8 yrs related experience (e.g. Regulatory Project Management)
- Preferably with 4 Yrs in Global Regulatory Affairs
- Experience working on late-stage filings preferred
- Advanced education or credentialing in regulatory affairs and project management preferred
- Significant experience in global drug development regulations
- At least two major eCTD registrations in the USA or more jurisdictions
- Understanding of scientific principles and regulatory standards
Benefits
- medical, dental, vision insurance
- 401(k) plan and company match
- short-term and long-term disability coverage
- basic life insurance
- tuition reimbursement program
- paid volunteer time off
- company holidays
- up to 80 hours of sick time
- up to 120 hours of paid vacation
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
Regulatory Project ManagementGlobal Regulatory AffairseCTD registrationsRegulatory operational supportIntegrated regulatory project plansRegulatory milestones reportingLate-stage filingsGlobal drug development regulationsScientific principlesRegulatory standards
Soft skills
CollaborationLeadershipProactive drivingCommunicationOrganizational skills
Certifications
Advanced education in regulatory affairsProject management credentialing