Dennis Wong

- Responsible for development and implementation of Global regulatory strategies (inc. US/EU/RoW) for development programs in cross-functional teams - Contribute into global clinical development program/project team objectives to support development/commercial Target Product Profile (TPP) - Lead Global RA team meeting for responsible projects to support global/regional clinical development and provide input into program resource estimates - Lead Global health authorities' interactions (inc. FDA and EMA meetings) - Provide directions to RA teams to ensure compliance with global regulatory requirements - Lead global submission planning activities to support global clinical trials and planned market approvals - RA strategy lead for development unit due diligence, portfolio integrations and divestment projects - Strategic guidance and functional support to global regulatory managers

- Define regional regulatory objectives and priorities covering Pharmaceuticals and Medical Devices portfolio based on business needs - Line management of country/clusters Heads of RAs direct reports in EMEA region consisting of >100 countries and provide strategic guidance and functional support to RA organization - Management of regional budget and support regional RA recruitments/resource management - Lead regional periodic regulatory meetings and represents the region in Global Leadership team - Oversee regional inspection/audit remediation activities to ensure compliance - Review and approve creation and implementation of regional regulatory processes/systems - Support organizational change management process and develop transition plan to support integration

- Oversee and manage strategic and operational priorities of the regional RA Pharmaceuticals department - Line management of regulatory affairs managers direct reports - Strategic regulatory partner for the Global/EMEA regional pharmaceuticals business franchise teams - Define and outline regulatory strategies and directions for development/lifecycle projects for regional pharmaceuticals portfolio in line with Global/regional objectives, including new MA, new indications, portfolio transfer/divestment - Responsible for departmental budget and recruitment/resource allocation - Lead health authority interactions including EMA parallel scientific advice and pipeline meetings - Troubleshoot and provide solutions to pharmaceutical regulatory issues throughout the region - Provide oversight on the design, creation and implementation of regional regulatory processes - Oversee and implement inspection readiness preparation activities

- Operational management of Pan-European pharmaceuticals portfolio - Develop regional regulatory strategies to support global/regional regulatory projects - Strategic and operational RA point of contacts for regulatory project submission and approval activities with health authority and cross-functional stakeholders - Operational lead in the preparation and submission of new MAs, clinical trials applications and life cycle submissions - Regulatory lead to Global development teams for new EU product submission - Provide support to health authority interactions - Deputize for the RA director in regional and global RA meetings - Provide regional regulatory support and solutions to regional/countries regulatory Heads/Managers - Liaise with regional pharmaceutical business on specific regulatory projects (e.g., support patent extension or generic differentiation) - Develop and implement regional RA processes - Provide EU regulatory assessment on global CMC change controls/labelling updates - Plan and implement remediation activities associated with inspection/audit findings - Management and provide support to third-party regulatory consultants - Lead and manage RA communications and develop joint processes with partner companies

- Act as lead quality/CMC assessor/reviewer of assigned assessment projects/activities - Mentoring and training of new associate pharmaceutical and scientific assessors - Complete relevant pharmaceutical and clinical assessment/review for new EU marketing authorizations (inc. Centralized as Rapp/Co-Rapp, Decentralized, Mutual Recognition and National EU procedures) - Managed and review all types of pharmaceutical variation applications (e.g., CMC and non-CMC) - Assessment of active substance master files (ASMF) - Brief UK CHMP representative on pharmaceutical/CMC related issues related to regulatory procedures - Manage and coordinate with the inter-disciplinary team to ensure delivery of assessment reports within agreed EU timelines - Complete written reports/papers for the EMA, national expert committees/advisory groups or inter-departmental working groups for specific assigned projects - Review UK public assessment reports (PAR) prior to publication - Provide scientific/CMC/regulatory advises to EMA/SAWP and national scientific advice procedures - Liaise with GMP Inspectorate to resolve issues identified during the assessment/review process

- Lead projects on new oral formulations/analytical development - Pilot and validation scale manufacture - ICH stability study management - Manufacturing equipment validation and calibration - SOP preparation and review

Responsibilities: - Duties included dispensing, clinical medicines review, aseptic manufacture, quality control and drug information.

Responsibilities: - Pharmaceutical R&D project on excipients compatibility and formulations stability studies of solid oral dosage forms.

Awarded BBSRC/GSK joint scholarship Professional experience:  Synthesis and characterisation of novel amphiphilic polymeric and oligomeric drug delivery systems  Preparation of amphiphilic nano-particulate delivery systems with cytotoxic drugs  In-vitro biological/ toxicological evaluation of drug delivery systems  HPLC method development for drug quantification and stability studies  Preparation of laboratory SOPs and review existing SOP  Undergraduate student supervision

 Graduated with 1st class Honours MRPharmS (2001 - 2010) GPhC (2010 - present)  UK Registered Pharmacist