Inamul Haque

Experience

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  Ranbaxy

  May 2013 - Apr 2015

  Research Associate

  • To provide scientifically rational responses to queries raised by Regulatory Agencies (US-FDA, WHO, EU, ANVISA, TPD-Canada, GCC, MoH-Malaysia, etc) on bioequivalence studies.• To perform literature search in support of dossiers.• To provide cogent and logical responses/clarifications to comments given by Regulatory Agencies during onsite inspections. • Address concerns raised by BE assessors/consultants of Reviewing Agencies/Product Partners regarding bioequivalence studies.• Support generation and review of Bio-summaries and Harmonization Documents to be submitted to Regulatory Agencies along with study report.Preparation of bio-study reports as per eCTD format.• Review Bioequivalence Summaries (EU Countries), Comprehensive Summary: Bioequivalence (Canada), Bioequivalence Trial Information Form (WHO), Office of Generic Drugs – Study Summary Tables & Clinical Summary Report (US-FDA) of Bioequivalence Study Reports to be included in final dossier.• Coordinate for providing inputs for the suitability of bioequivalence study data as per Regulatory Requirements for filing of product dossiers.• Liaising with various cross functional teams for providing scientifically rational responses to queries raised by Regulatory Agencies (USFDA, WHO, Europe, Canada, ANVISA, Australia, Malaysia and CDSCO-India)• Provide documents to be submitted at the time of product renewals and variation filings.• Playing a role in defining the global regulatory strategy, identifying the critical issues and sharing lessons learned.• Facilitating consistency in regulatory documentation and strategies by critically reviewing documentation and integrating regulatory trends. Show less

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  SUN PHARMA

  May 2015 - Mar 2016

  Research Scientist

  Regulatory dossiers preparation and reviewBE Summary as per different regulatory Authority guidelines. CS-BE, BTIF, EU, US. CS Protocol and report reviewRegulatory QueriesODR data Regulatory Authority Inspection support

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  PharmaLex

  Apr 2016 - Apr 2019

  Senior Regulatory Affairs Specialist

  - Preparation of Regulatory dossiers for submission to Regulatory Agencies (in US, Europe, Russia- CIS and India)- Review of CMC (BPRs, BMRs, PDRs, specifications, stability data, dissolution data, validation protocols and reports, etc) and Clinical Study documents (protocol, data, report)- Gap analysis of documents based on Agency requirements- Life cycle management of approved products- eCTD publishing- Responding to deficiencies/queries raised by Regulatory Agencies- Development of regulatory strategies - Regulatory Intelligence- Maintain knowledge and understand SOPs, Client SOPs/directives and current regulatory guidelines as applicable to services provided- Coordination and communication with project teams, clients, internal departments and Regulatory bodies at global level for all operational procedures to support global projects- On-site customer support, development and trouble shooting Show less

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  Montajat Pharmaceuticals

  Apr 2019 - Sept 2019

  Senior Executive

  Authoring and review of high quality Regulatory Affairs dossiers.Publishing. Regulatory compliance.Regulatory guidelines.Regulatory Intelligence.Project lead.Presentations on Regulatory Guidelines.Training team members.Meetings and coordination with International stake holders.

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  Klybeck Life Sciences AG

  Oct 2019 - Aug 2021

  Senior Regulatory Affairs Specialist

  Authoring and review of high quality Regulatory Affairs dossiers.Regulatory compliance.Regulatory guidelines.Regulatory Intelligence.Project lead.Training team members.Meetings and coordination with International stake holders.

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  Jamjoom Pharma

  Sept 2021 - now

  Regulatory Affairs Lead

  Managing end to end Regulatory projects, plans and submissions.Guiding team members on executions and regulatory expectations/guidance.Authoring and review of high quality Regulatory Affairs dossiers for Global submissions.Review of administrative, quality and clinical sections.eCTD, NeeS, non-CTD submissions.Planning new filings and life cycle management eCTD Publishing Regulatory compliance.Regulatory guidelines.Regulatory Intelligence.Leading multiple projects and markets.Training team members.Meetings and coordination with International stake holders/affiliates/marketing teams. Show less