Regulatory Affairs Lead - NCE

Job Summary
We are looking an experienced Lead Regulatory Affair to oversee the review of critical documents, ANDA (Abbreviated New Drug Application) submissions, and deficiency responses, ensuring compliance with regulatory guidelines and internal checklists within the Global Regulatory Affairs department for formulations. You will be responsible for preparing regulatory strategy notes, regulatory due diligence and gap analysis for leverage products in consultation with vertical head. Review and closure of change notifications (CRNs) for under development, under review and launch products, providing launch support w.r.t regulatory decisions and provide regulatory guidance/updates to the cross functional teams.
Roles & Responsibilities

>  The ability to develop and execute the regulatory filing & approval strategy by identifying the most appropriate regulatory pathway, assessing approval requirements across d...