What are the responsibilities and job description for the Regulatory Affairs Project Lead position at garonitpharmaceutical?
Regulatory Affairs Project Lead
đź“Ť 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