Regulatory Affairs - Topical & OSD - US Market & IPR-OSD

WE ARE HIRING URGENT REQUIREMENT

M. Pharma | Regulatory Affairs Topical & OSD | US Market & IPR (Formulation OSD)

One of our reputed clients a leading pharmaceutical organization is hiring for three critical positions in US Regulatory & IPR domain.

Location: Bachupally, Hyderabad, India

Position 1: Regulatory Affairs Topical / Derma (US Market)

Role Focus:

Regulatory professionals with strong expertise in Topical & Derma product filings within US Regulatory Affairs (RA-CMC-SPD) for Formulation OSD products.

Qualification: M. Pharmacy

Experience: 5+ Years

Preferred Candidate Profile:

Hands-on experience in RA-CMC Derma & Topical product filings

Currently working in US Regulatory Affairs (CMC Derma / Topical)

Strong understanding of U.S. Food and Drug Administration regulatory requirements

Position 2: Regulatory Affairs Reviewer (CMC OSD US Market)

Qualification: M. Pharmacy

Experience: 510 Years (ANDA / NDA US Market)

Key Skills:

ANDA / NDA (505(b)(2)) submissions

eCTD, Module 2 & 3 documentation

CMC Review

Manufacturing & Analytical Documents

ICH & US FDA Guidelines

Position 3: IPR Intellectual Property Rights (Formulation OSD)

Qualification: M. Pharmacy

Experience: 510 Years (Formulation IPR Only)

Key Skills:

IP Landscape Analysis

FTO & Non-Infringement

Para IV, NCE

ANDA Litigation

Patent Filing & Prosecution

Regulatory Support

Send your updated CV to: careers@inveaxglobal.com

Subject Line: Mention the Position Applied For

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Warm Regards,

Nitten Musale

Founder & Director

• Inveax Global Consulting & Exportss