KARAGATE KOMINTA

• Regulatory strategy leads for pharmaceutical products and medical devices, and provides regulatory advice and support to internal stakeholders and commercials
• Responsibilities include:
• Planning and managing regulatory submissions according to global filing plans and local requirements, including developing and implementing innovative regulatory strategies
• Participating in creating regulatory documents and meetings aligned with the global regulatory strategy while guiding regulatory mechanisms to expedite the registration process and minimize the time needed to introduce products to the market in Thailand
• Reviewing registration documents to ensure completeness and compliance with local standards facilitates successful submissions
• Compiling the product dossier and all supporting documents to enhance the likelihood of approval
• Offering regulatory advice to colleagues within the company based on expertise in relevant regulatory documentation and procedures to assist in problem-solving
• Monitoring emerging regulatory guidelines and legislation and providing ongoing local regulatory intelligence related to specific projects and any changes in the local regulatory affairs environment that may impact the regulatory strategy or plan
• Review and approve promotional and non-promotional materials to ensure compliance with local regulations and internal standards

Responsible for managing the preparation and submission of product registrations and amendments and performing pharmacovigilance activities relating to pharmaceutical products and medical devices (class 1-4) for ophthalmic and aesthetics.

• Planning and managing regulatory submissions for new drugs, generics, medical devices, and variations to ensure compliance with global/regional filing plans and local regulatory requirements, including the development of regulatory strategies designed to enable patient access by national legislation and regional regulatory requirements, in addition to developing scientific advice with health authorities
• Participation in developing regulatory documents and meetings by the global/regional regulatory strategy while providing regulatory direction on regulatory mechanisms to speed up the registration process and shorten the timeframe to place products into the Thai market
• Providing regulatory advice to colleagues within the company based on knowledge of relevant regulatory documentation and procedures to assist in problem-solving
• Collaborated with cross-functional teams to ensure alignment on regulatory requirements and timelines.
• Implementing a pharmacovigilance program that reports adverse events to ensure patient safety and regulatory compliance

• Provided regulatory support including product registration and line extensions to support product launches, and tender applications
• Ensured regulatory compliance with local regulatory requirements and internal procedure
• Participated in project teams, provided guidance in regulatory affairs expertise, and supported other team members, including marketing team
• Reviewed technical and quality documents, including product specifications and analytical methods, and evaluated complaints and deviations

• Performed product registration and was responsible for regulatory activities relevant to labeling and pharmacovigilance support, including Company Core Data Sheets (CCDS)
• Ensured regulatory compliance with local and global regulatory requirements
• Participated in project teams to provide guidance and support in areas of regulatory expertise

• Prepared submission packages for regulatory submissions to ensure compliance with FDA, and Institution Ethics Committees (IECs) or Institution Review Boards (IRBs)
• Collected and maintained required site essential documents, and reviewed Informed Consent Form (ICF) and Patient Information Form
• Provided regulatory support to sponsor, project teams and collaborators
• Updated and tracked changes in regulatory legislation and guidelines

• Responsible for the compilation of registration dossiers for submissions to regulatory authorities
• Follow-up with regulatory authorities to obtain rapid approvals from FDA, Thailand
• Maintained and updated product registration and regulatory compliance files

• Maintained full responsibility for development of suitably robust formulations and provided solutions to problems occurring in product development
• Supported analytical method development team in completion of development activities and production team in transfer of formula and validation of new manufacturing process
• Prepared all documentation relevant to formulation and process development in support of the registration of drug products