Regulatory Affairs Project Lead

Garonit Pharmaceutical • Fairfield, NJ

13h • Onsite

About The Position

Garonit Pharmaceutical is seeking a Regulatory Affairs Project Lead to drive regulatory strategy and execution across our growing product portfolio. This role will play a key part in advancing our pipeline from development through commercialization, with a strong focus on ANDA submissions and lifecycle management.

Requirements

• Bachelor’s degree in Life Sciences or related field
• 3–5 years of Regulatory Affairs experience (ANDA/generics required)
• Hands-on experience preparing regulatory submissions
• Strong knowledge of FDA, CFR, and ICH guidelines
• Experience in a cGMP pharmaceutical environment
• Excellent project management and organizational skills
• Strong technical writing and cross-functional collaboration abilities

Nice To Haves

• Regulatory Affairs Certification (RAC) or PMP
• Experience with infection prevention products

Responsibilities

• Lead the preparation, assembly, and submission of regulatory filings (ANDA focus)
• Manage cross-functional projects from development through commercialization
• Develop and maintain regulatory strategies for product approvals and lifecycle management
• Prepare product dossiers and Drug Master Files (DMFs)
• Collaborate on international regulatory submissions
• Track project timelines, risks, and progress (Gantt charts, reporting, etc.)
• Review and approve GMP documentation (SOPs, protocols, reports)
• Stay current on FDA regulations and provide internal guidance/training
• Identify process improvements and support continuous improvement initiatives

Benefits

• Be part of a growing U.S.-based pharmaceutical manufacturer
• Work on impactful products in infection prevention and healthcare
• Collaborative, fast-paced environment with high visibility

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 11-50 employees