Assistant Manager Formulation IPR

Job description

**Job Description Assistant Manager, IPR Formulations** **Department:** Intellectual Property Rights (IPR)**Designation:** DM/AM Formulation IP**Experience:** 1214 years**Education:** M.Pharm (Pharmaceutics) mandatory or equivalent technology Masters degree; Ph.D. / LLB / PG Diploma in IPR, Patent Law or Regulatory Affairs preferred Role Objective To independently support and manage formulation IP activities for Alkems global product portfolio, including patent searches, FTO, strategy clearances, patent drafting and prosecution, litigation support, oppositions, due diligence and attorney coordination across key markets such as US, EU, India, Canada, Australia and other global territories. Key Responsibilities - Conduct patentability, landscape, validity, infringement and Freedom-to-Operate (FTO) assessments for formulation products. - Support product strategy clearances, non-infringing formulation approaches, design-around strategies and early launch opportunities. - Draft, review and coordinate filing/prosecution of patent applications relating to formulations, drug delivery systems, dosage forms and related technologies. - Prepare office action responses in coordination with external patent attorneys and internal R&D teams. - Support patent litigation, Paragraph IV matters, oppositions, revocations, invalidation actions and related technical/legal analysis. - Assist in discovery activities, document review, claim charts, expert/counsel coordination and litigation strategy support. - Conduct IP due diligence for in-licensing, out-licensing, product acquisitions and business development opportunities. - Monitor innovator and competitor patents, patent applications, exclusivities and regulatory/IP developments across relevant markets. - Coordinate with R&D, Regulatory, Business Development, Portfolio, Legal, Commercial teams and external attorneys for timely IP inputs and clearances. - Prepare concise management updates, risk assessments, patent summaries and strategic recommendations. Required Skills and Competencies - Strong understanding of pharmaceutical formulation patents, lifecycle management and global patent laws, especially US, EU, India, Canada and Australia. - Hands-on experience in FTO, patent drafting, prosecution, opposition, litigation support, discovery support and due diligence. - Good working knowledge of patent databases such as Derwent, scifinder, Espacenet, USPTO, WIPO and other patent/regulatory sources. - Strong analytical thinking, attention to detail and ability to translate complex patent issues into practical business recommendations. - Good leadership, cross-functional coordination, stakeholder management and communication skills. - Ability to handle confidential IP, litigation and business information, strong ownership, commitment to timelines and result-oriented approach. Preferred Industry Background Pharmaceutical, specialty pharma, generics, innovator companies, or IP consulting/law firms handling pharmaceutical formulation IP matters. Overall Candidate Fit Candidate should demonstrate a strong blend of scientific understanding, legal awareness, commercial mindset, confidentiality, and practical IP judgment to support Alkems formulation portfolio and business development initiatives. Confidential For Internal Recruitment Use