Job Description:
• Partner with the program Global Regulatory Lead (GRL) to co-lead and facilitate Global Regulatory Team (GRT) meetings
• Proactively drive GRT and submission working groups to ensure deliverables
• Develop and maintain integrated regulatory project plans
• Prepare and present reports on regulatory milestone status and potential critical issues
• Drive decision-making processes and escalate issues as needed
• Conduct lessons learned sessions and track project variances
Requirements:
• Bachelor's degree required
• Minimum of 12 yrs related experience in the pharma/biotech industry
• 4 or more years in Global Regulatory Affairs
• Significant experience in global drug development regulations, regulatory submissions, compliance, business systems technology and process
• Experience with original and supplement/variations in multiple markets (e.g US, EU, JP and ROW)
• Understanding of scientific principles and regulatory standards/requirements relevant to global drug development and post-market support
• Excellent verbal and written communication skills
• Strong ability to collaboratively lead without line authority
• Expertise with project management software and tools (e.g. MS Project, OnePager, Office Timeline, SharePoint)
Benefits:
• 401(k) Plan: 100% match on the first 6% of contributions
• Health Benefits: Two medical plan options (including HDHP with HSA), dental, and vision insurance
• Voluntary Plans: Critical illness, accident, and hospital indemnity insurance
• Time Off: Paid vacation, sick leave, holidays, and 12 weeks of discretionary paid parental leave
• Support Resources: Access to child and adult backup care, family support programs, financial wellness tools, and emotional well-being support
• Additional Perks: Commuter benefits, tuition reimbursement, and a Lifestyle Spending Account for wellness and personal expenses