Director, Global Regulatory Affairs Operations – Project Manager
Project ManagerProject ManagerFull TimeRemoteTeam 1,001-5,000Since 1999H1B SponsorCompany SiteLinkedIn
Location
New Jersey
Posted
25 days ago
Salary
$195.5K - $293.3K / year
Bachelor Degree12 yrs expEnglish
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
Job 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
