Assistant Manager IP

Azurity Pharmaceuticals is a privately held, specialty pharmaceutical company that focuses on innovative products that meet the needs of underserved patients. As an industry leader in providing unique, accessible, and high-quality medications, Azurity leverages its integrated capabilities and vast partner network to continually expand its broad commercial product portfolio and robust late-stage pipeline. The company’s patient-centric products span the cardiovascular, neurology, endocrinology, gastro-intestinal, institutional, and orphan markets, and have benefited millions of patients. For more information, visit www.azurity.com.

Azurity Pharmaceuticals is proud to be an inclusive workplace and an Equal Opportunity Employer. Azurity's success is attributable to our incredibly talented, dedicated team that focuses on benefiting the lives of patients by bringing the best science and commitment to quality into everything that we do. We seek highly motivated individuals with the dedication, integrity, and creative spirit needed to thrive in our organization.

Job Summary

Azurity is seeking a highly skilled patent professional to join the growing Intellectual Property (IP) team, driving global product development through robust Intellectual Property analysis. The candidate does comprehensive IP analyses, identifies patent barriers, and delivers actionable insights to guide product development and lifecycle management. The candidate will play a key role in protecting Azurity’s innovation pipeline, navigating global IP landscapes, and supporting regulatory submissions with sound IP strategies.

Principle Responsibilities:

1. IP Strategy & Risk Management

• Conduct comprehensive patent landscape and whitespace analyses across global markets (India, US, EU, China, Brazil, Japan, etc.) to identify IP barriers and opportunities.
• Draft, file, and prosecute patent applications (including formulation, process, and use patents) to strengthen the company’s IP portfolio.
• Perform Freedom to Operate (FTO) analysis to assess risk and enable informed product development and commercialization decisions.
• Predict potential blocking patents and assess the probability of patent grant or litigation risks.

      2. Portfolio & Lifecycle Intelligence

• Monitor competitor activities, brand pipelines, patent expiry timelines, and ongoing clinical trials to perform portfolio planning.
• Provide IP diligence and strategic input during product selection and pre-launch planning.

      3. Regulatory & R&D Support

• Assist the Regulatory affairs team in preparing label carve-outs, patent certification statements (e.g., Paragraph IV), and regulatory exclusivity statements (180-day exclusivity, orphan drug designation, pediatric exclusivity).
• Stay current with evolving FDA and international regulatory guidelines and their intersection with IP protection.

      4. Data & IP Intelligence Tools

• Efficiently utilize IP and competitive intelligence platforms including IQVIA, PACER, PatSnap, IPD Analytics, and internal tools for data-driven decision-making.
• Utilize global databases such as USPTO, WIPO, EPO, IPO, and country-specific portals.

Qualifications

• Advanced degree in Pharmacy, Life Sciences, Chemistry, or related scientific discipline.
• 6–8 years of relevant experience in Intellectual Property domain within the pharmaceutical or life sciences industry, preferably with a focus on formulations.

Preferred Skills & Attributes

• Proficiency in conducting FTOs, landscape studies, and invalidation searches using commercial IP databases.
• Exposure to 505(b)(2) regulatory pathways and experience working on complex formulation IP.
• Understanding of the US Orange Book, FDA exclusivities, and Hatch-Waxman Act implications.
• Strong scientific acumen with the ability to interpret formulation technologies and related patents.
• High attention to detail, critical thinking, and problem-solving mindset.

By applying for this role, you confirm that you are mentally and physically capable of fulfilling the job responsibilities detailed in the job description without any restrictions. If you have any concerns or even the slightest disability that may affect your ability to perform the job, please inform HR in advance.