Suresh Mani

About Suresh Mani

Regulatory Affairs and Quality Assurance leader with 19+ years of experience supporting global pharmaceutical development and lifecycle management across US, EU, AfME, and APAC markets. Proven expertise in global regulatory submissions, CMC strategy, and sterilization assurance, spanning sterile and solid oral dosage forms.Demonstrated success in leading new registrations, post‑approval changes, Annual Reports, and Renewals, with strong capabilities in eCTD CMC authoring for sterile products (liquid injections, lyophilized products, ampoules, pre‑filled syringes) as well as solid oral dosage forms. Recognized for aligning regulatory strategy with scientific rigor to drive compliance, speed, and sustainable product supply.Core Strengths• Regulatory Strategy & Execution: Lead high‑quality global submissions and complex CMC activities aligned with health authority expectations• CMC Expertise – Sterile & Solid Orals: Deep technical oversight across formulation, manufacturing, and control strategies• Sterilization Assurance: Subject matter expertise in microbiological and sterilization assurance for sterile drug substances and products• Cross‑Functional Leadership: Strategic collaboration with internal teams and CMOs on dossiers, audits, inspections, and due diligence• Risk & Policy Leadership: Translate global regulatory guidance into actionable strategies and risk mitigation plans• People & Capability Development: Mentor teams and deliver training to strengthen regulatory excellence• Lifecycle & Documentation: Author regulatory strategies, position papers, and drive process improvementsAreas of ExpertiseGlobal Regulatory Filings (US, EU, AfME, APAC)|eCTD CMC – Sterile & Solid Oral Dosage Forms |Labeling & Lifecycle Management |Regulatory Intelligence & Strategy |Stakeholder Engagement & TrainingKey Skills: Regulatory Leadership | CMC | Regulatory Submissions | People Management | Compliance Management | Gap Analysis | Process Improvement

Experience

1. Group Lead

   화이자

   Nov 2025 — Present · Chennai, IN

Education

• C.L Baid Metha College of Pharmacy, Chennai

  B. Pharm, Pharmaceutical Sciences

  2001 — 2005

• JSS College of Pharmacy, Ooty

  M.Pharm, Pharmaceutical Analysis

  2005 — 2007

Skills

• Gmp
• V&V
• Regulatory Requirements
• Pharmaceutics
• Regulatory Affairs
• Pharmaceutical Industry
• Sop
• Fda
• Formulation
• Glp
• Validation
• Oncology
• Abbreviated New Drug Application (Anda)
• Ectd
• Generic Programming
• Cleaning Validation
• Anda
• Quality Assurance