Qvents

Qvents

Discussion forum for Pharma Quality events, Regulatory Actions

Warning letters, 483s, Recalls, Import Alerts, Audit observations

Lupin
Designation : Senior Executive
Function : Project Management
Functional Area : R&D Project Management
Job Role Summary : Screening/selection of molecules for identifying opportunities for  Niche dosage forms, Tracking and trending developments around Upcoming Technology
Job Profile :

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.
Job Requirements :

Good knowledge of Pharma portfoli Management, Regulatory landscape

Project and Portfolio Management experience

Work / Job Experience : 4-7 Years
Type of Experience : Pharma Formulations Projects Management
Academic Qualifications :

Masters in Pharmacy or Business Administration
 

To apply for this job please visit careers.lupin.com.

No links available.