Farid Uddin Email & Phone Number

Mumbai, Maharashtra, India

• Accountable for the delivery of regulatory milestones for less complex projects through the product lifecycle.• Participate in the development, communication, lifecycle management and review of the CMC Regulatory Strategy Document for smaller-scoped projects.• Execution of CMC documentation including IND/CTA, NDA/BLA/MAA, postapproval supplements, annual reports, registration renewals and responses to health authority questions per established business processes and systems.• Experience in reviewing scientific information and assessing whether technical arguments are clearly presented, and conclusions are adequately supported by data.• Applying oral and written communication skills and the ability to communicate issues in a succinct and logical manner. Strong listening skills.• Applying understanding of related fields (e.g., manufacturing, analytical, quality assurance).• Flexibility in responding to changing priorities or dealing with unexpected events.

India

Regulatory strategyBeing a Regulatory science lead in RACMC worked closely with cross-functional teams to develop regulatory strategies for post-approval activities of the product. Assessed regulatory requirements, analyzed risks and provided strategic recommendations to ensure compliance with applicable regulations.Regulatory Submissions Authored module 3 eCTD dossier sections of multiple dosage forms including ophthalmic dosage forms, solid oral dosage forms and parenteral dosage forms for post-approval regulatory submissions globally.Authored module 2.3 QOS in WHO format for renewal, variation and new product submission in Sub-Saharan African countries.Regulatory ComplianceEnsured manufacturing and quality control processes comply with regulatory requirements. Worked closely with manufacturing, quality assurance and quality control teams to establish and maintain compliant manufacturing practices, documentation and controls.Life cycle management activitiesCoordinated and supported post-approval regulatory activities, such as variations, Health authority query responses and renewals. Also, assessed and managed regulatory risks associated with product changes or deviations from approved specification.Regulatory intelligenceStayed updated on regulatory guidelines, requirements and industry trends. Monitored regulatory changes and provided analysis and recommendations to the manufacturing teams to ensure compliance and mitigate any potential risks.Overall, my work experience at a leading global pharmaceutical company has equipped me with the necessary skills and expertise to excel in the field of CMC Regulatory Affairs.

Paonta Sahib, Himachal Pradesh, India

Document Preparation and Review• Collection and Compilation of documents for filing Generic Drug Products-tablets and capsulesfor filing Marketing Authorization Applications via National and MRP/DCP procedures; variations and notifications in CTD /ACTD Formats.• Response to NODs.• Preparation of renewal documents for renewal of products in APAC and ROW.Coordination with Plant and Departments• Co-ordination with manufacturing facility/Contract-manufacturing facility to facilitate timely documents for regulatory submissions.• Critical Review of documents from various departments for compliance and adequacy with EU Regulatory requirements. • Follow-up with the respective departments in case of correction / rectification required in the submission documents, if any deficiency is observed.• Assessment and Review of change controls w.r.t regulatory impact and filing strategy with respect to reporting of changes to the agency.• Timely submission of changes/variations enabling no impact on product continuity. Updation and Application• Keeping updated about current Regulatory guidelines / requirements (ICH/Europa (Eudralex)/hma/TGA).• Delivering presentations to keep the team updated for regulatory guidelines.• Maintaining continuity of commercialized products • Ensuring continuity of commercialized products and compliance of products with respect toapproval.• Organizing database for repository of documents and commitments to the agencies. • Support to production, planning through participation and/or timely feedback before S&OP NP CFT.

Baddi, Himachal Pradesh, India

M.Pharm, Pharmaceutics, I St Division

B. Pharm, Pharmacy, 1St Division