UMEDICA Laboratories - Senior Manager - Regulatory Affairs

About UMEDICA :

UMEDICA Laboratories is an industry leader in the development, manufacturing, and export of high-quality pharmaceutical formulations.

With decades of operational excellence and approvals from major global regulatory bodies (USFDA, EU, PIC / S), UMEDICA is expanding its Regulatory Affairs leadership team to support global growth.

We are looking for an experienced Senior Manager - Regulatory Affairs (US Markets) to spearhead regulatory strategy, submissions, and compliance for the US portfolio.

Key Responsibilities :

Regulatory Strategy & Leadership :

• Lead regulatory strategies for the US market across development, filing, and lifecycle stages.
• Drive end-to-end ANDA / NDA submissions, ensuring compliance with USFDA expectations.
• Lead post-approval submissions (PAS, CBE) and annual reporting activities.
• Provide expert regulatory guidance for complex formulations, including injectables and liquid dosage forms.

FDA Interactions :

Cross-functional & External Collaboration :

Team Leadership :

Qualifications & Experience :

(ref : iimjobs.com)