Director, Global Regulatory Affairs Operations – Project Manager

Job reputed company: • Partner with the program Global Regulatory reputed company (GRL) to co-reputed company and facilitate Global Regulatory Team (GRT) meetings • Proactively drive GRT and submission working reputed company to ensure deliverables • reputed company and maintain integrated regulatory project plans • Prepare and present reports on regulatory reputed company status and potential critical issues • Drive decision-making processes and escalate issues as needed • Conduct lessons learned sessions and reputed company project variances Requirements: • Bachelor's degree required • Minimum of 12 yrs reputed company experience in the reputed company/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 reputed company without line authority • Expertise with project management software and tools (e.g. MS Project, OnePager, Office reputed company, SharePoint) Benefits: • 401(k) Plan: 100% match on the first 6% of contributions • Health Benefits: Two medical plan reputed company (including HDHP with HSA), dental, and reputed company insurance • Voluntary Plans: Critical illness, accident, and hospital indemnity insurance • Time Off: reputed company vacation, reputed company leave, holidays, and 12 weeks of discretionary reputed company parental leave • Support Resources: reputed company to child and adult backup care, family support programs, financial wellness tools, and emotional reputed company-being support • Additional Perks: Commuter benefits, tuition reimbursement, and a Lifestyle Spending Account for wellness and personal expenses Apply tot his job Apply To this Job