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.

What You'll Do

• 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

What We're Looking For

• 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

Preferred:

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

Why Join Garonit

• 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