Inamul Haque

* Preparation and review of regulatory affairs documentation for submission to various Regulatory Agencies across the globe
* Review of CMC and Clinical Study documents
* Electronic submissions
* Life cycle management of approved products
* Variation filings
* Responding to deficiencies/queries raised by different Regulatory Agencies
* Assist in the development of regulatory strategies
* Liaise with global team to support global projects

Preparation of Regulatory Affairs dossiers.
Review of technical data and reports.
Life cycle management.
Correspondence with Regulatory Agencies.
Coordination with cross functional teams.
Liaise with global team to support global projects.

Preparation of regulatory affairs documentation for submission to various Regulatory Agencies across the globe predominntlyforEurope, US
* Review of CMC and Clinical Study documents
Electronic submissions
* Life cycle management of approved products
* Variation filings
* Responding to deficiencies/queries raised by different Regulatory Agencies
* Assist in the development of regulatory strategies
* Maintain knowledge and understand SOPs, Client SOPs/directives and current regulatory guidelines as applicable to
services provided
* Liaise with clients in the tracking and status update of project plans
* Liaise with global team to support global projects
* On-site customer support, development and trouble shooting
* Conducting feasibility studies for validating capability and functionality

Preparation and review of clinical study reports as per ICH format
* Performing eCTD and non-eCTD compilations
* Writing scientifically rational responses to queries raised by different Regulatory Agencies (of US, EU, Australia, GCC,
Canada, Malaysia, Thailand, Singapore, etc) on bioavailability/bioequivalence studies
* Performing literature search in support of submitted dossiers
* Generation and review of bio-summaries and other technical documents to be submitted to Regulatory Agencies
along with study report
* Preparing and reviewing 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
* Preparing various documents for Regulatory submission on case to case basis
* Addressing concerns raised by BE Assessors/Consultants of Reviewing Agencies/Product Partners regarding
bioequivalence studies
* Providing cogent and logical responses/clarifications to comments given by Regulatory Agencies during onsite
inspections (US-FDA, ANVISA, UK-MHRA, WHO, etc.)
* Suppporting development of protocols for conducting bioequivalence studies by reviewing and providing inputs in
accordance with regulatory recommendations
* Facilitating strategic & operational performance of Quality Department involving development & implementation of
standardized quality system processes and undertaking close review of standards for quality assurance & quality
control whilst adhering to regulatory compliance
* Interacting 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)
* 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
* Streamlining the process of management of queries placed by Regulatory Agencies by designing a SOP to facilitate
handling, preparation and review of response. Also, developed a system to facilitate tracking of response.
* Investigating and evaluating existing technologies
* Coordinating the CRO/vendor activities and/or data and providing valuable inputs to support development and
regulatory compliance