Ankit Mishra

About Ankit Mishra

I am an accomplished Analytical R&D professional with over 17 years of experience in the pharmaceutical industry, specializing in analytical research and development, validation, and lifecycle management for solid oral dosage forms. My expertise lies in method development, global regulatory submissions, and compliance management, where I have successfully driven regulatory success and operational excellence. I am passionate about leveraging my skills in project management and cross-functional team leadership to contribute to a growth-oriented organization.Throughout my career, I have spearheaded global regulatory submissions, including CTD and eCTD dossier preparation, achieving successful approvals with zero critical observations. I possess a strong command of Quality by Design (QbD) principles and have a proven track record in managing and mentoring teams to enhance technical capabilities and performance excellence. My commitment to compliance and audit readiness has been instrumental in ensuring adherence to international guidelines and standards.Key Achievements- Led a team of 10–12 scientists in Analytical Research & Development, ensuring timely project execution and regulatory compliance- Spearheaded analytical development and regulatory submission activities for regulated markets, contributing to successful product approval in Australia (2025) and received an Appreciation Certificate for the achievement- Coordinated cross-functional collaboration with Formulation R&D, Regulatory Affairs, QC, and QA for seamless dossier submission and commercialization- Mentored and trained team members on advanced analytical techniques, regulatory documentation, and quality systems- Supported technology transfer activities from R&D to plant scale, ensuring smooth scale-up and validation.Email: a••••••••@gmail.com | Contact No:+91••••••••45

Experience

1. Assistant Manager

   Zim Laboratories Limited

   Apr 2022 — Present · Nagpur, IN

   In my current role as Assistant Manager in Analytical Research & Development, I lead the analytical R&D strategy for solid oral dosage formulations. I execute method development, robustness optimization, and validation while ensuring compliance with ICH Q2(R2) and regulatory frameworks across EU, UK, and Brazil markets. I drive global CTD/eCTD dossier preparation and manage deficiency responses to ensure seamless approvals. My responsibilities also include designing analytical evaluations for development and stability batches to support accelerated product commercialization timelines. I govern data integrity through rigorous review processes and lead nitrosamine impurity risk assessments to align with global regulatory expectations.Achievements: I successfully led a team of 10–12 scientists, ensuring timely project execution and regulatory compliance. I spearheaded analytical development and regulatory submission activities that contributed to successful product approval in Australia (2025), earning an Appreciation Certificate for this achievement. Additionally, I coordinated cross-functional collaboration for seamless dossier submissions and mentored team members on advanced analytical techniques.

Education

• Sant Gadge Baba Amravati University, Amravati

  Master of Science - MS, Organic Chemistry

  2006 — 2008

• SVKM's Narsee Monjee Institute of Management Studies (NMIMS)

  Master of Business Administration - MBA, Operations Management

• IPER

  Diploma in Pharmaceutical Quality Control & Quality Assurance Management (DPQCQAM), Quality Control & Quality Assurance in Pharma

  2012 — 2013

• Sant Gadge Baba Amravati University, Amravati

  Bachelor of Science - BS, Botany; Zoology; Chemistry

  2003 — 2006