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

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)

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

Director, Global Regulatory Affairs Operations – Project Manager

Key skills