Head Formulation & Development-ANDA

Job Summary:

We are seeking an experienced Head of Formulation Development (R&D) to lead and oversee formulation activities for oral solid dosage forms targeting regulated markets, including the US and EU. The ideal candidate will have extensive leadership experience in formulation R&D, strong technical expertise in complex generics and novel drug delivery systems, and a proven record of successful USFDA submissions.

Key Responsibilities:

• Lead formulation development for new and existing oral solid dosage (OSD) products.
• Oversee the complete development lifecycle from pre-formulation to technology transfer.
• Ensure regulatory compliance with USFDA, EU, and other global standards.
• Collaborate with cross-functional teams such as QA, QC, Regulatory Affairs, and Manufacturing.
• Drive innovation through cost-effective and efficient formulation strategies.
• Provide technical direction for complex generics and novel drug delivery system development.
• Manage and mentor large formulation development teams to ensure timely project delivery.