1. Prashant B. Chudasama E-mail ID: prashant8978@yahoo.co.in
Current Job Profile & Responsibilities:
• Leading and strategically aligning Global Regulatory Operations, CMC and
Compliance team to achieve submission timelines and organizational goals
with effective and efficient utilization of available resources.
• Defining and deploying global regulatory strategies, goals and submission
policies/plan for drug product development and new marketing applications
and extension to newer markets for Solid Orals and Injectable Dosage forms.
• Playing a key role in CFTs to guide on global regulatory strategies at different
stages of product life cycle.
• Developing, deploying and effective monitoring of new and supplemental
regulatory submission plan in line with organizational goals.
• Ensuring appropriate and timely response to HAs deficiencies.
• Consult and liaise with cross functional team heads to meet new,
supplemental and deficiencies submissions.
• Terminal review of key modules/documents before submission to HA.
• Life cycle management of drug product submissions.
• Single point of contact for all regulatory liaisons related aspects for HAs,
Global Partners and internal and external stakeholders to create an effective
and more cohesive relationship.
• Playing key role in major decision makings pertaining to regulatory evaluations
and finalizing new markets.
• Uses deep subject matter/functional expertise, influence and process skills to
help stakeholders to identify and meet their high priority needs while
considering cultural and diversity implications.
• Encourages informed risk-taking and acts as a catalyst for innovation;
generates practical, sustainable and creative options to solve problems and
create business opportunities, while maximizing utilization of existing
resources.
• Up-keeping of self and team on different regulatory guidance & current
updates and helps in effective interpretations and smooth implementations.
• Timely and proactively assessing regulatory changes utilizing depth and
breadth of experience and its business impact and smooth implementation.
• Responsible for organizing and optimizing the required/available resources
through effective supervision of departmental staff and activities by creating
healthy and co-operative environment.
• Co-ordination and Support during HA inspections and its compliance as per

2. defined timelines.
• Review and updates of regulatory SOPs and guiding to cross functional
departments on key SOPs as and when required.
Achievements@MSN:
• Ensured first US ANDA, EU DCP and Canada ANDS filing and acceptance from
green filed project site within 6 months as per most recent submission
requirements.
• 20+ US ANDA (mostly NCE-1 filings), EU DCP and Canada ANDS submissions
in two years period from green field site without RTR of any the ANDA filed so
far and achieving acceptance of submission for review.
• ANDA Tentative approval (NCE-1 project) in less than 15 months period from
date of filing.
• 2200+ MA submissions and 800+ approvals so far for Global Emerging Markets
in different continents in compliance to current HA regulations and
requirements.
• Successful site approval from US FDA (3 sites), EU Authority, WHO-Geneva
(Twice) and 30+ HAs from Emerging markets.
• Organization and Implementation of eCTD, SPL and DMS software systems.
• Improvement of Regulatory environment within organization.