Senior Manager - Intellectual Property - Formulation (11-20 yrs)

Position: Senior Manager- IPR (Formulation)

Location: Mumbai (work from office)

Skills Required: Candidate must have experience in Pharma domain

Responsibilities:

- Review patent landscape, patent clearance report and invalidity reports.

- FTO analysis and discuss with R&D on strategy clearance.

- Design ANDA filing strategy, monitor competitive intelligence and suggest early launch prospects.

- Prepare patent invalidity reports, support in patent litigation, identify blocking patents / applications and take appropriate measures like opposition and revocation to mitigate IP risk.

- Create IP asset by filing, prosecution and grant of patents.

- Propose IP driven product opportunities for early launch for all markets.

Experience:

- Strong technical and IP knowledge on formulation patents for different regulated markets.

- Excellent understanding of infringement analysis, freedom to operate and patent invalidity analysis

- Strong experience of different dosage forms like solid oral, injectable, ophthalmic, derma and complex products like respiratory.

- Should collaborate effectively with R&D for strategy clearances.

- Should have experience of patent litigation, opposition, revocation and preparing patent invalidation reports

- Proficient in patent drafting, filing and prosecution and co-ordinate with outside attorneys to manage patent portfolio globally.

- Strong knowledge of IP law of different countries like US, Canada, Brazil, Mexico, Russia, Australia, India etc.

- Design ANDA filing strategy and launch timelines for US market.

- Strong exposure on IP law of other territories like LATAM, Asia, Canada, AU etc.

- Identify and propose new product opportunities (generic and 505(b)(2) products) for early market entry

- Provide IP support to different stakeholders like portfolio, business development, project management, marketing, regulatory etc.

- Attend cross functional meetings and provide IP summary to stakeholders. Leadership/Managerial Attributes