Rahul Balip

About Rahul Balip

Highly Seasoned & Accomplished Medical Affairs Specialist with more than 23 years of…

Experience

1. Dgm - Medical Affairs

   Lupin Pharmaceuticals

   Aug 2018 — Present · Mumbai, IN

   Won accolades for successful time-bound implementation of a medical information project of large proportion in a record six months, saving a huge cost of approximate 19 million INR for the company.Excelled in clinical development for 11 clinical trials (phase 3 and phase 4) in the therapies of ophthalmology, covid infection, oncology, gynecology.Successfully collaborated and completed multiple publications related to cardiology and diabetology.Instrumental in the international launch of 3 branded generics molecules (one of the brands worth 150 million USD for the company).Medical support for audits and regulatory activities, thereby mitigating a huge risk of repercussions from the regulatory authorities.Played a pivotal role in providing extensive medical support for analyzing unmet need and creating medical rationales for 3 drugs internationally.Implemented & enhanced the research activities & Capabilities, generation of clinical/epidemiological evidence, Investigator Studies Program.Handled medical queries/complaints, gathered the required information, analyzed and submitted adverse events.Prepared & project managed cross-functional teams for FDA submissions like PMA, PMA-S, Real-time review, Clinical updates.Experienced in research techniques used in formulating drugs, data modelling, and optimization process.Ensured product compliance with each country\'s registration or listing requirements prior to product marketing.Provided expert advice to management, ensuring product claims & marketing materials, compliance with global regulations.Represented the organization in high-level negotiations with the ability to resolve conflict in a constructive manner.Detailing on the current standard of care (SOC) for the target diseases by developing and executing Global Medical Research (GMR) strategies (IST program, registry, other phase IV when needed) as well as performing opportunity and gap analyses.

Skills

• Social Media
• Powerpoint
• Microsoft Excel
• Research
• Marketing
• Microsoft Office
• Public Speaking
• Customer Service
• Microsoft Word
• Leadership