Intellectual Property Executive R&D

Skills:
Regulatory Compliance, Patent Life Cycle Management, Pharmaceutical Patent Law, Prosecution Skills, Communication Skills, Hatch-Waxman provisions,

Company Overview
Hetero Drugs is an Indian pharmaceutical company and the world's largest producer of anti-retroviral drugs. Hetero's business includes APIs, generics, biosimilars, custom pharmaceutical services, and branded generics.

Job Summary
We are looking for a proactive and detail-oriented IPM professional with a strong background in pharmaceutical formulation R&D. The candidate will be responsible for managing patent-related activities including drafting, filing, and prosecution, conducting FTO (Freedom to Operate) analyses, and supporting product development with robust IP strategies.

Key Responsibilities

1. Drafting and filing patent applications related to formulation and pharmaceutical products.
2. Conducting patent invalidation studies and preparing oppositions.
3. Preparing IP landscape and competitive intelligence reports to support R&D and business decisions.
4. Performing FTO (Freedom to Operate) analyses for new and existing products.
5. Reviewing patent certifications (Para IV filings, etc.) and handling label clearances in compliance with regulatory frameworks.
6. Collaborating with formulation scientists, regulatory, legal, and business teams to align IP strategies with product goals.
7. Monitoring and assessing third-party patent activity and alerting stakeholders to potential risks or opportunities.
8. Assisting in response to patent litigation or regulatory queries as required.

Desired Candidate Profile

1. M. Pharm (Pharmaceutics mandatory) with 3-8 years of experience in IPM within a formulation R&D environment.
2. Sound understanding of pharmaceutical patent law, Hatch-Waxman provisions, patent life-cycle management, and regulatory pathways.
3. Experience in drafting, filing, and prosecuting patents in India, US, and EU.
4. Knowledge of patent databases and tools (e.g., Derwent, PatBase, USPTO, Espacenet).
5. Strong analytical and communication skills with attention to detail.

Job Title: Executive/ Sr Executive
Department: Intellectual Property Management / R&D
Reports To: General Manager
Experience: 3-8 Years
Qualification: M. Pharm (Pharmaceutics Must)
Location: Jeedimetla, Hyderabad