IPRM - PDR Formulation R&D

Navlakha Management Services; Mumbai; Hybrid; INR 1,500,000 - 2,300,000; Full time

Job summary

Navlakha Management Services in Mumbai seeks a seasoned professional for IPRM PDR | Formulation R&D. The role encompasses patent landscape reporting, FTO clearances, and global patent handling across multiple markets while supporting formulation R&D activities.

The candidate should have 5-7 years of experience in Pharmaceutical IPR / Patent and Formulation R&D with a strong grasp of Hatch-Waxman, due diligence, and prosecution history. Mumbai-based opportunity with exposure to diverse markets.

Qualifications

• Pharma/IPR domain experience required.
• 5-7 years of relevant experience preferred.

Responsibilities

• Prepare Patent Landscape Reports and FTO Clearances.
• Handle patent activities for USA, Europe, WHO, Domestic, Australia, New Zealand, Russia & ROW markets.
• Exposure to Hatch-Waxman Litigation.
• Conduct Patent Due Diligence including Patent Extension, SPF, Orange Book, Composition, Method of Treatment & API Patents.
• Formulation Design-Around Strategies covering isomerism, dosage regimen, method of treatment, particle size, etc.
• Prepare Patent Certifications, Exclusivity Statements, Cover Letters & Patent Expiry analysis.
• Knowledge of patent databases such as SciFinder, Cortellis, Orbit, IQVIA, Espacenet & WIPO.
• Patent Drafting, Prior Art Searches and Prosecution History review.

Skills

Patent landscape

FTO clearances

Hatch-Waxman

Due diligence

Design-around

Drafting

Prior art

Prosecution history

Education

B.Pharm / M.Pharm / M.Sc.

Tools

SciFinder

Cortellis

Orbit

IQVIA

Espacenet

WIPO

Job description

Job Title: IPRM PDR | Formulation R&D

Location: Mumbai

Experience: 5-7 Years

Qualification: B.Pharm / M.Pharm / M.Sc.

Job Description

We are looking for a professional with relevant experience in Pharmaceutical IPR / Patent and Formulation R&D activities.

Key Responsibilities:

• Preparation of Patent Landscape Reports and FTO Clearances.
• Handling patent activities for USA, Europe, WHO, Domestic, Australia, New Zealand, Russia & ROW markets.
• Exposure to Hatch-Waxman Litigation.
• Patent Due Diligence covering Patent Extension, Supplementary Protection, Orange Book, Composition, Method of Treatment & API Patents.
• Formulation Design-Around Strategies covering isomerism, dosage regimen, method of treatment, particle size, etc.
• Preparation of Patent Certifications, Exclusivity Statements, Cover Letters, Side-by-Side Labeling Carve-outs & Patent Expiry analysis.
• Knowledge of patent databases such as SciFinder, Cortellis, Orbit, IQVIA, Espacenet & WIPO.
• Patent Drafting, Prior Art Searches and Prosecution History review.