Regulatory & Clinical Manager

• Sep 2022 - Present

Global Regulatory Compliance Manager

• Aug 2016 - Present

• Managing and reporting of GRA Compliance activities including, procedure management, risk assessments, change controls, deviations & CAPAs.• Representing change control meeting for GRA assessments.• Maintaining QMS system for Global Regulatory Affairs ensuring continuous compliance with QMS procedural documents and trainings.• Managing departmental training profile, curricula, and compliance reports.• Coordinating regular review of global GRA procedural documents and contribution towards development, implementation and maintenance of departmental processes and procedures.• Providing Regulatory assistance for internal & external audits (including customer audits, PV and GMP audits).• Working closely with Pharmacovigilance and clinical teams to monitor safety reports.• Regular participation in continuous improvement initiatives to deliver business excellence like update of publishing software, implementation of GRA archive and view tool etc.• Regular involvement in Inter-departmental interactions with Regulatory, Pharmacovigilance, clinical; and commercial teams as well as interacting directly with health authorities on regular basis as required.• Preparing compliance status reports, quarterly reports to higher management.• Representing Global Regulatory Affairs in R&D Quality Council meetings with top management. Show less

Global Regulatory Compliance & Intelligence Manager

• May 2019 - Sep 2022

• Maintaining the Regulatory Intelligence database in Regulatory Intelligence SharePoint site with ongoing monitoring and surveillance of the global regulatory landscape including HA websites, trade associations. • Communicating forthcoming changes to regulatory environment in all key markets (AU, USA, Europe, UK, Canada, LATAM etc) and share with key stakeholders or teams. Where applicable coordinating responses to consultations with relevant SMEs and submission to health authorities.• Working as SME for all aspects of product lifecycle, monitor and assess the new regulations and perform impact assessment for Seqirus related products and processes. Show less

Senior Regulatory Advisor

• May 2016 - Aug 2016

• Acting as TBS administrator for Seqirus and CSL for maintaining activities around annual fee payments, GMP pre-clearance for overseas manufacturers, Manufacturer’s licence maintenance and invoice management.

Regulatory Affairs Associate

• Dec 2007 - May 2016

• Providing of regulatory advice and support throughout development and throughout all product stages thereafter; formulation advice for restricted and permitted substances; label claim restrictions; maximum allowable quantities; artwork and label reviews and claims substantiation. • Prepared response to Regulatory inquires. • Maintained the labeling control process for tracking. • Compiling and submitting responses to TGA letters and annual reports for approved products. • Reviewed documents including labeling drafts and validation and stability protocols and reports. • Maintained product core dossier and product master files. • Assessed change controls and prepared submissions arising from the change control process. • Preparation of product dossiers in CTD & NeeS compliant format (recently trained). • Direct dealing with TGA and other regulatory bodies. • Preparing and maintaining of clients GMP Agreements • Preparation and submission of new substance (proprietary ingredient) applications. • Maintenance of company licenses to Manufacture; GMP license; Import and Export licences. • Submission of Import and Export Permit applications- products & materials (with AQIS and other bodie Registration Support Service • Assisting client to compile regional regulatory dossier. (includes New Zealand and Asia Pacific countries, Malaysia, Thailand, Korea, Vietnam, Singapore, Hong Kong etc) • Preparation of dossiers as per requirement in the country of sale. (first hand experience of preparing dossiers for New Zealand, Malaysia, Thailand, Korea & Hong Kong) • Providing/obtaining certification. e.g. Halal, BSE/TSE, Allergen Status, Country of Origin, Certificate of Representation. • Managing of changes to products and coordinate collation of supporting documentation. • Registration of product on Australian Register of Therapeutic Goods.(with a thorough knowledge of eBS) • A thorough knowledge about the regulatory requirements in South East Asian markets Show less

Compliance Associate

• Mar 2006 - Dec 2007

• Efficient development, implementation and management of quality systems site wide, which include change control system, corrective & preventative system, training system and document control. • Assistance and support through customers audits on site. • Re-implementation of change control system which involved update of SOP’s, change control forms, training sessions for each department. Also organizing & conducting change control meetings, monthly reporting and troubleshooting. • Development & implementation of an efficient CAPA (corrective & preventative action) system. Reviewing & closing out of actions from CAPA system, monthly reports, assigning of tasks and troubleshooting. • Conducting training session and awareness workshops site wide for different quality management systems. • Improving the documentation control system site wide ensuring that the standard operating procedures and other relevant paperwork is accurate and up to date. • Involved in designing of internal audit program. • Involved in various Kiazen and lean Six Sigma projects. Show less

Product Review Scientist

• Jul 2004 - Mar 2006

• Reviewing of quality data and preparing quality reports with conclusion and recommendations on the compliance of the product to the set specification. • Assistance to product review committees in resolving process problems. • Preparing of reports in accordance with the agreed APR schedule and in accordance with the approved Standard Operation Procedure. • Reviewing of product quality data which include the statistical review of QC Batch summary analytical data, Process and Method Validation reports, In-process Production data and batch records, OOS, Deviation and Complaints databases, and Change Control databases. • Reviewing of all the lab results statistically using “QI analyst” (statistical software). • Interpretation of stability results using ICH guidelines. • Retrospective validation of products using statistical tools including control charts, process capability and histograms Show less

Quality Control Analyst (Analytical Services Quality Assurance Department)

• Jun 2004 - Jul 2004

• Performed analytical testing and accurate documentation of results relating to release testing • Reporting, reviewing and checking of results or other documents (e.g. SOP’s, MTD’s, certificates of analysis, investigation reports) and preparation of a summary or report. • Performed defined analytical testing and project work in special projects like occupational Hygiene/ environmental monitoring groups. • Performed analytical testing and accurate documentation of results relating to release testing • Reporting, reviewing and checking of results or other documents (e.g. SOP’s, MTD’s, certificates of analysis, investigation reports) and preparation of a summary or report. • Performed defined analytical testing and project work in special projects like occupational Hygiene/ environmental monitoring groups.

Production Pharmacist (sterile & dermatological section)

• Jun 2002 - Dec 2003

• Basic wet chemistry testing of products using UV/IR etc. • Stability testing of products. • Supervision of production activities in sterile and dermatological sections. • In process checking of production activities. • Preparation and keeping up-to-date all the SOPs and other documents related to the production area. • Control of bio burden of area and air handling system of sterile section. • Preparation of periodic reports as per company’s requirement. • Basic wet chemistry testing of products using UV/IR etc. • Stability testing of products. • Supervision of production activities in sterile and dermatological sections. • In process checking of production activities. • Preparation and keeping up-to-date all the SOPs and other documents related to the production area. • Control of bio burden of area and air handling system of sterile section. • Preparation of periodic reports as per company’s requirement.