M.S. Renganathan

JOB PROFILE

• Drug Master Files (DMF) submissions to different geographies and CEP dossiers with EDQM in e-CTD format
• Writing High Quality CMC documentation.
• Responses to Chemistry, Manufacturing and Control (CMC) deficiencies & Administrative queries
• Life Cycle Management viz. Annual updates / Technical & Administrative Amendments / CEP revisions / EU Variations
• Handling change management and customer communications
• Review of Executed Batch Production Records, Specifications, Standard Testing Procedures, Analytical Method Validation documents, Stability documents and other QA/QC documents for error free submissions
• Sound knowledge on ICH and other regional regulatory guidelines
• Quality Overall Summaries (QoS) and Quality based review (QbR)
• Letter of Access / Authorization (LoAs) & Document of Access (DoAs) issuance
• Good exposure on FDA's administrative requirements like Establishment registration, Self-identification, NDC code, GDUFA user fee etc.
• Other administrative documents in support of Regulatory filings
• Co-ordination with Cross Functional teams to finalize regulatory submissions in a timely manner.
• Experience in regulatory audit

KEY ROLES

• Active member in the New Product Development team in Regulatory Front
• Customers Support
• Review of Outsourced Vendors of Starting Materials and Intermediates
• Active member in the 'Strategic Team' for Cost Excellence Projects and other technical changes intended for Regulatory submissions

CHANGE MANAGEMENT AND OTHERS

• Evaluation of proposed changes to categorize in line with the respective Regulatory guidelines. Ensuring adequate scientific justification for the proposed changes in line with the regulatory requirements.
• Hands on experience on D-U-N-S # / Self-identification / GDUFA cover sheet generation / NDC labelling creations / CARES ACT
• Hands on experience on regulatory submissions using eCTD (compilation and publishing), CESP, CDER, CDER NEXT GEN

AUDIT EXPOSURES

• Participated as an active member in US-FDA audit for the API facilities.
• Conducted “Regulatory Compliance Audits” for the products undergone Regulatory submissions at respective manufacturing
  sites (In-house & CMOs) to ensure compliance.
• Audited outsourced intermediate vendor sites in Regulatory front to
  ensure compliance.

• Same as current Job profile
• Review of Product Development Record
• Active member in new product development team in regulatory front (Finalisation of specificaitons of API, Intermediates, KSM)

• Worked as Synthetic chemist
• Involved in new API process development
• Handled various organic reactions to synthesize the target molecules of customer requirement

• Worked as Synthetic chemist
• Handled various organic reactions to synthesize the target molecules of customer requirement
• Involved in process development of Active Pharmaceutical Ingredients (API)s