Rahul Mandsaurwale

About Rahul Mandsaurwale

Accomplished Pharmaceutical professional with deep knowledge of the Generic Commercial, R&D, Regulatory, Quality, Supply Chain and drug development life cycle aspects of generic drugs as well as a keen understanding of commercial and financial analysis. Background includes a growing deal sourcing network, Asset Integration, alliance management and project management along with a track record of success at the most preeminent fast growing companies in the generic drug industry. Uniquely skilled at coordinating global cross-functional teams. Currently managing identification, assessment and negotiations for newer leads to in-license, co-develop or acquire niche high barrier to entry, complex dosage forms including topicals, inhalants, transdermals, injectables and controlled substances. Expert in portfolio execution and project management.• Currently leading Alliance Management & BD function for complex dosage form development for Lupin through various international partners and commercial in-house projects in a role that involves identification of partners, due diligence assessments, negotiation of agreements through successful execution of resulting alliances from contractual and milestone standpoint.• Single point of contact for company’s global teams involved in strategic product pipeline portfolio for late stage business contracts and closed transactions.• Extensive experience in Regulatory Affairs – Review & organization of NDA/ANDA/DMF/CTD/MAA/Amendments/Supplements/Annual Reports/Post-approval changes/labeling for submission to the FDA; Technical communication with FDA on various aspects.• Served as single-point Project Manager for planning and execution of Sterile Injecatbles Development for small molecules and biologicals. Managed contract vendors for routine clinical and development studies.Specialties: Portfolio Development, Tech Transfer and Project Management,

Experience

1. Senior Director

   Lupin Pharmaceuticals

   Jul 2022 — Present · Baltimore, MD, US

Education

• Devi Ahilya Vishwavidyalaya

  Master of Pharmacy, (Medicinal and Pharmaceutical Chemistry)

• Devi Ahilya Vishwavidyalaya

  Bachelor of Pharmacy (Pharm.D.), Pharmacy

Skills

• Technology Transfer
• Regulatory Submissions
• Formulation
• Cross-Functional Team Leadership
• R&D
• Clinical Trials
• Regulatory Affairs
• Lifesciences
• Anda
• Regulatory Requirements
• Change Control
• Quality System
• Pharmaceutical Sales
• 21 Cfr Part 11
• Capa
• Product Launch
• Gxp
• Aseptic Processing
• Chemistry
• Hplc
• Pharmacovigilance
• Gmp
• Market Access
• CRO
• Pharmaceutical Industry
• Sop
• Fda
• Biotechnology
• Oncology
• Validation
• Sales Effectiveness
• Drug Development
• Biopharmaceuticals
• Drug Delivery
• Glp
• Pharmaceutics
• Drug Discovery
• Project Management
• Quality Assurance
• Generic Programming