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:

- Lead FDA meeting preparations-Type B/C meetings, briefing packages, and follow-up communications.

- Handle controlled correspondences, addressing regulatory queries and clarifying development pathways.

Cross-functional & External Collaboration:

- Partner with R&D, Quality, Manufacturing, and Clinical teams to align regulatory requirements with development goals.

- Represent Regulatory Affairs in internal meetings and external regulatory interactions.

- Support commercial launch readiness and lifecycle management activities.

Team Leadership:

- Lead, mentor, and develop a team of regulatory professionals.

- Oversee workload planning, performance management, and capability building.

Qualifications & Experience:

- 13-15 years of strong experience in US Regulatory Affairs with proven success in ANDA/NDA filings.

- Hands-on experience with FDA meetings, controlled correspondence, and complex regulatory negotiations.

- Strong understanding of US drug development, cGMP regulations, and USFDA submission pathways.

- Excellent leadership, communication, and stakeholder management skills