M M Akhtar Qureshi

About M M Akhtar Qureshi

Pharmacy post graduate with 12+ years of experience in Pharma Regulatory Affairs: • Enthusiastic Regulatory Affairs Specialist with extensive experience in laying down Regulatory strategy of product development for major markets like US, EU and CA [NDA/ANDA/ANDS/MAAs] markets. • Vast experience in Health Authority interactions (FDA/HC/EMA/others) for regulatory strategy agreements, including CC\'s, pre-NDA, Scientific Advice and responding to deficiencies (Q&A\'s). • Expert in navigating regulatory approval procedures for diverse drug product dossiers, including Parenteral Dosage Forms (Liquid, Sterile powders, Emulsion, Suspension injections and drug-device combination products like Pre-filled syringes), Ophthalmic and Solid oral dosage forms. • Well Versed in the compilation and comprehensive review of all ICH CTD sections and Modules (1, 2, 3, 4 & 5), focusing on CMC, micro (sterility assurance package) and device-related documentation. • Proficient in interpreting and applying guidelines from EMA, ICH, FDA and ISO guidance as well as new guidance concerning DDC\'s. • Adroit in review of Design control documentation (Design History File) of drug-device combination products. • Extensive experience in handling of post-approval changes for EU, US and CA markets. • Adept in orchestrating and executing global regulatory strategies. • Experience in providing training to colleagues/ junior level staff and delivering presentations on various regulatory topics.

Experience

1. Regulatory Affairs Cmc Specialist

   Pharmathen

   Jan 2022 — Present

Education

• Nagpur University

  Master of Pharmacy, Quality Assurance

  2010 — 2012

• Nagpur University

  Bachelor of Pharmacy - BPharm, Pharmacy

  2006 — 2010

• Bench Mark Lean Six Sigma

  Six Sigma