Regulatory Affairs Project Lead

📍 Fairfield, NJ (Onsite)

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.

• →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

• 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

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