Job Title:
Associate Director, RA Submissions
Function:
Regulatory Affairs Group
Sub Function:
Regulatory Product Submissions and Registration
Category:
Senior Manager, Regulatory Product Submissions and Registration (P8)
Location:
Hybrid – Raritan, NJ / Titusville, NJ / Horsham, PA, United States
Date Posted:
April 15, 2025
Requisition Number:
2506229584W
Work Pattern:
Hybrid Work
Closing Date:
May 02, 2025 (may be extended)
Description:
Johnson & Johnson is seeking an Associate Director, RA Submissions to lead global regulatory dossier planning and execution for key pharmaceutical products, particularly in the U.S. and EU markets. This senior role involves working cross-functionally with Regulatory Affairs teams, product teams, and publishing partners to ensure high-quality, timely submissions aligned with global registration strategies.
Key Responsibilities:
Lead the operational strategy and execution of global regulatory submissions for assigned products
Create and manage complex dossier plans, ensuring alignment with regulatory and product team goals
Act as SME for global registration dossiers; manage historical context and submission data
Liaise with internal teams (GRT, SWG, GDT, PCT) to ensure smooth regulatory execution
Review and verify completeness of submission documents
Identify risks, manage resource constraints, and resolve process inefficiencies
Track submission milestones and report key metrics
Support continuous process improvements for submission management
Qualifications:
Bachelor’s degree in Pharmacy, Life Sciences, Regulatory Affairs, or a related field
Minimum 8 years’ experience in regulatory affairs or submission management
Strong understanding of pharmaceutical product development
Familiarity with regulatory information systems and global submission requirements (FDA, EMA, etc.)
Excellent interpersonal and communication skills
Experience leading cross-functional teams and influencing decision-making
Able to work in a dynamic, matrixed environment
Travel: up to 5% (domestic/international)
Compensation & Benefits:
Base Salary Range: $120,000 – $207,000 (U.S.)
Eligible for performance-based bonus
Benefits include: medical, dental, vision, life, disability insurance, legal services, 401(k), pension plan
Paid time off includes:
Vacation: up to 120 hours/year
Sick Time: 40–56 hours/year (location dependent)
Holidays: up to 13 days/year
Personal/Family Time: up to 40 hours/year
More information: Johnson & Johnson Careers - Benefits
Equal Opportunity Statement:
Johnson & Johnson is an Equal Opportunity Employer. Qualified applicants will receive consideration without regard to race, gender, disability, veteran status, or other protected characteristics. Accommodations available upon request.
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