Senior Executive : IPMG
Lupin
Job Description
Keeping a track of FDA Guidance’s for Product Development, Peer ANDA approvals, Legal Updates & Drug Shortages. 505b2 concepts: Identifying and creating differentiated 505b2 Pipeline
Product Identification
Responsibilities include screening/selection of molecules across various therapeutic segments & building a robust Product Pipeline, based on IP Challenges, product complexities and identifying opportunities and Innovative/ Niche dosage forms. IQVIA Updation: GAP Analysis to be carried out to generate tailor made reports e.g. Dosage Form, Platform Technology, Therapeutic Category etc. Tracking of the developments around Upcoming Technology, evolving Trends, & Mergers & Acquisitions.Keeping a track of FDA Guidance’s for Product Development, Peer ANDA approvals, Legal Updates & Drug Shortages. 505b2 concepts: Identifying and creating differentiated 505b2 Pipeline
Management of Clinical Trial & Pipeline Advocacy
Screening various data sources such as Press Release, SEC Filings, Corporate Presentations & Clinical Trial Databases.
Collating Data around different stages of development & maintaining CT Tracker.
Portfolio Management
Build a Diversified Generic Portfolio with strategic focus on Exclusive First to File Opportunities, FTM/CGT/Priority Review & Limited Competition. Providing Internal Governance to various Technical teams for Product Development, Pipeline Prioritization & Product Launch. Work Experience4-7yrs
Education Masters in Pharmacy or Business AdministrationCompetencies CollaborationStakeholder ManagementStrategic AgilityDeveloping TalentResult OrientationInnovation & CreativityCustomer CentricityProcess Excellence
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