Santosh Awale

About Santosh Awale

With over 12 years of progressive leadership at Raptim Research, I currently uphold the role of General Manager, leveraging my expertise in medical writing and regulatory affairs for clinical trials. My tenure has honed key skills in team management and professional development, contributing to the company\'s mission of advancing medical research. I am committed to fostering a culture of innovation and excellence, aligning my strategic vision with Raptim\'s values. Our team\'s dedication to ethical research practices not only supports the organization\'s goals but also sets new industry standards.

Experience

1. CRO Specialist

   Crescent Pharma Ltd

   Apr 2025 — Present · GB

   Currently leading and overseeing Bioavailability/Bioequivalence (BA/BE) studies at Crescent Pharma UK with a focus on: • Strategic selection and coordination with CROs for BA/BE study execution • Budget planning, negotiation, and finalization for clinical studies • Designing study protocols with a strong emphasis on scientific and regulatory requirements • Sample size estimation and statistical input for study planning • Ensuring end-to-end regulatory compliance across study phases • Critical review of key clinical documents including Protocols, Clinical Study Reports (CSR), and other submission materials • Ongoing monitoring and oversight of study progress and quality • Preparing and responding to queries from global regulatory authorities

Skills

• Regulatory Affairs
• Pharmaceutical Industry
• Sop
• Pharmaceutics
• Good Laboratory Practice (Glp)
• Validation
• Standard Operating Procedure (Sop)