Category

Description

• To lead the Formulation operations for development of OSD formulations (Generic & 505(b)(2) business for regulated markets.
• Strong experience working on oral solids formulations including extended release, immediate release.
• To develop key expertise, technologies, and product portfolios for the company.
• To manage and supervise R&D scientific team for product development, operations & to enable technology transfer.
• To develop and manage program budgets and timelines (Budget Management, Program Management, Portfolio Management) that aligns with corporate goals & strategy
• To develop key strategies to reduce cost of development and IP & litigation hurdles.
• To establish product development and process development systems, procedures & guidelines in line with current quality and regulatory needs.
• To be able to handle product approval process and manage pre-approval inspections by FDA and other regulatory agencies.
• Direct a team of product development team and BE study experts for evaluation of the products prior to dosing for bioequivalence (BE) or clinical studies to enable dossier submissions.
• To coordinate with Regulatory Affair department to prepare dossier documents like Quality Overall Summary (QOS), Product Development Report (PDR), Question Based Review (QBR) Filing and to enable address and respond deficiencies/queries raised by the regulatory agencies.
• To synchronize the product development, process characterizations and technology transfer activities.
• To enable the organization in leveraging the generic dossier into emerging markets to improve bottom-line of an organization.
• To coordinate activities with CMOs, contract third party vendors, clinical research organizations (CRO) and other related functions for efficient planning & execution.

• Should have experience in Product development and should have lead a sizable team of product development experts.
• Should have experience in handling all stages of pharmaceutical product development from product selection to successful commercialization.
• Extensive project management skills with global leadership experience, specializing in solid and liquid oral dosage forms.
• To be able to clearly understand complexities around the product (which include IP, regulatory, Bioequivalence & formulations) and guide the team to strategies the development & in technical troubleshooting.
• Actively participate in creation of project pipeline, product portfolio for the organization along with the experts from Business Development, Intellectual Property, Research & Development, API-Chemistry, and Regulatory teams.
• Continually create & maintain the list of optimum number of projects for development for subsequent years with all assessment done at appropriate time(s).
• Active participate in pre-assessment activities for some of the projects like sample RLD procurement, API evaluation, CRO finalization, scientific advices & other relevant services to decide on do-ability of project.
• Creating, allocation and monitoring the budget for all the selected projects and maintain status report for quick review of senior management.

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