Hainin Chuang

Experience

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  GlaxoSmithKline

  Apr 2011 - Dec 2011

  Regulatory Affairs & Marketing Trainee
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  Novartis Chile

  Aug 2012 - May 2017

  Senior Regulatory Affairs Associate

  • Regulatory maintenance of registered products, including minor and major submissions to the local health authority ( ISP - CHILE)• Prepare regulatory applications (including extension use of indications, dosage, new strengths etc) of registered products and maintain registrations in accordance to the local legislation• Perform product registration in accordance with local strategies and launch plan • Prepare and submit safety and non-safety changes to the local Health Authority in a timely manner• Keep current with the local regulatory landscape including prescription medicines and non-prescription medicines• Ensure all compliance KPIs are met accordingly to company policy.• Liaise and coordinate with internal subject matter experts to respond to submission deficiencies identified during regulatory review• Provide regulatory support and expertise to the business and cross-functional teams and working collaboratively as a valued member of various cross-functional teams• Building and maintaining strong relationships with external stakeholders to support execution of local regulatory strategies Show less

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  Austral Divers

  Nov 2012 - Dec 2013

  Instructor

  Scuba Diving Instructor

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  Novartis

  Jan 2015 - May 2017

  DRA Regional Project Coordinator

  Latam Regulatory affairs coordinator for development projects, responsible for leading the regional submission strategy accross the region supporting latinamerican countries in their requirements, in terms of clinical trials, dossier preparation, communications within the regional and the global level. - Coordination and support to LatinAmerica countries according to the Regulatory Strategy of Neuroscience Franchise development projects. - Act as regulatory contact for divisional regulatory teams. - Facilitator between the countries Latam countries and Headquarter (HQ) in Basel, Switzerland, in terms of communications and regulatory implementation related to development projects. - Support to the countries in terms of their specific local Health Authorities Requirements. - Leading transformation, and management improvement projects, regulatory intelligence, data management and unifying regulatory tools, within latam countries and alignment according to HQ requirements. Show less

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  Novartis, Australia & New Zealand

  Aug 2018 - Feb 2024

  After my secondment, I returned to regulatory affairs full-time with an operational focus, accountable for the project management of regulatory affairs and operational projects to support the divestment of Novartis generics division.- Experienced in cross-functional team coordination, delivering successful outcomes.- Expert in defining regulatory, quality, safety, and reimbursement requirements for brand divestments, securing on-time approvals.- Skilled in developing detailed project management plans, identifying key stakeholders, and tracking milestones.- Proactively identifies and mitigates risks, ensuring smooth project implementation.- Focused on enhancing efficiency, meeting health authority regulations, and aligning activities with global strategies (all aspects of regulatory strategy, including clinical, CMC and risk management requirements, and oversight of strategic labelling requirements) Show less I worked part-time in a seconded role, whilst continuing to work part-time within regulatory affairs, duties included:• Engaging and working collaboratively with global stakeholders (internal and external) to facilitate and enhance the value proposition. Identifying and highlighting gaps in data.• Supporting PBAC Reimbursement submissions for IHD franchise (Immunology, Hepatology and Dermatology). Performing systematic literature reviews, disease overview and support drafting the main body of the submission, including clinical and economical claim. Show less - Expertise in navigating the complex regulatory landscape of Australia and New Zealand.- Preparation and submission of regulatory applications, ensuring strict adherence to local legislation and global policies.- Maintenance of product registrations through effective coordination with local health authorities. (including but not limited to minor and major submissions, Cat 1s, CMC, Clinical, Safety, PSURs, RMP, Nitrosamines, ad-hoc projects).- Collaboration with internal subject matter experts and cross-functional teams to address regulatory deficiencies (including but not limited to CMC, Clinical, Safety, PSURs, RMP, Nitrosamines, ad-hoc projects).- Establishing and fostering strong relationships with external stakeholders to execute robust local regulatory strategies.- Meticulous record-keeping and maintenance of regulatory databases to ensure data integrity.- Consistent delivery of high-volume workloads within tight timeframes, meeting all internal KPIs and project deadlines. Show less

  • Senior Regulatory Affairs Operational Excellence & Compliance Associate

    Mar 2022 - Feb 2024

  • Patient Access and Healthcare Systems - Secondment

    Apr 2021 - Mar 2022

  • Senior Regulatory Affairs Compliance Associate

    Aug 2018 - Mar 2022
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  Organon

  Feb 2024 - now

  AP Associate Director Regulatory Affairs, Regional Project Manager