Arif Nadaf

About Arif Nadaf

I am a Formulation development Scientist having experience in generic and differentiated topical pharmaceutical product development for regulated markets including the US, EU, and India. My core strengths lie in QbD-driven product development, DoE-based optimization, and regulatory-compliant documentation.Throughout my career, I have worked cross-functionally with Regulatory Affairs, Quality Assurance, Analytical, and Supply Chain teams to support ANDA filings and lifecycle documentation. I’ve also authored technical dossiers, formulation justifications, and risk assessments (FMEA), supporting licensing and regulatory interactions. I’m passionate about accuracy, integrity, and clarity in scientific communication, and eager to contribute to a research development, global regulatory or medical writing fields driving compliance, innovation, and patient impact. Let’s connect if you’re looking for someone who bridges formulation science with regulatory and medical writing excellence.

Experience

1. Formulation Scientist

   Dr. Reddy's Laboratories

   Aug 2022 — Present

   Spearheaded end-to-end development of topical pharmaceutical products, including creams, gels,ointments, and lotions in accordance to regulated markets. Applied Quality by Design and Design of Experiments approaches for robust formulation design,parameter optimization, and control strategy alignment with ICH Q8–Q10 principles. Performed in-depth formulation characterization using Texture Profile Analysis, Rheology,Viscosity, Mucoadhesion, IVRT, and Microscopy. Developed comprehensive technology transfer documentation, including QTPP, CQA, CPP, CMA,Risk Assessments (FMEA), and Batch Manufacturing Records (BMR) to support scale-up andvalidation. Authored and maintained Product Development Reports (PDRs), Raw and finished productspecifications, formulation justifications, and Module 3 CTD dossiers for regulatory submissions.

Education

• Jamia Hamdard

  Master's degree, Pharmacy

• University of Mumbai

  B.pharm, Pharmacy

  2016 — 2020

• Maharashtra State Board of Secondary and Higher Secondary Education (MSBSHSE)

  Higher secondary education, Science

• Maharashtra State Board of Technical Education (MSBTE)

  Diploma in pharmacy, Pharmacy