KARAGATE KOMINTA

Serving as a Regulatory Strategy Consultant to offer services including applications for marketing authorization (product registration), license renewal, and post-approval amendment submissions, as well as ongoing maintenance throughout the product lifecycle. My responsibilities include:

• Planning and strategically managing regulatory filings to ensure compliance with local requirements while aligning with business goals for timely approvals.
• Conducting gap analyses to identify potential issues that could impact the feasibility of product registration and approval for FDA submissions.
• Overseeing the creation and maintenance of product information documents (Package Inserts, Patient Information Leaflets, SmPC, Instructions for Use, and labelling) as well as managing translations.
• Managing multiple high-stakes projects, consistently meeting strict timelines.

Spearheaded regulatory strategy for various products, including pharmaceuticals, medical devices, and cosmetics, while providing regulatory guidance and support to stakeholders. My core responsibilities included:
• Planning and managing regulatory filings and product registrations in accordance with global filing plans and local requirements, including developing and implementing effective regulatory strategies.
• Collaborating in creating regulatory dossiers and participating in meetings that align with the global regulatory strategy to expedite the registration process for the Thai market.
• Maintaining and updating technical dossiers, licenses (including renewals), notifications, and certificates to ensure compliance with regulatory requirements for pharmaceuticals and cosmetics (dermatological products), biologics (Botulinum toxin) and high-risk medical devices (dermal fillers).
• Providing regulatory advice to stakeholders based on expertise in relevant regulatory documentation and procedures to assist in problem-solving.
• Managing labeling, package inserts (IFUs), product information files (PIF), and reviewing and approving promotional and non-promotional materials to ensure compliance with regulations and internal standards.

Regulatory lead for four(4) business units managed the preparation and submission of product registrations and amendments, as well as conducted pharmacovigilance activities related to pharmaceutical products and medical devices (Classes 1-4) in the ophthalmic and aesthetics sectors. My responsibilities included:
• Planning and managing regulatory submissions for drugs (ICH CTD) and medical devices (CSDT) to ensure compliance with global and regional filing plans and local requirements.
• Participating in the development of regulatory documents and meetings aligned with global and regional regulatory strategies while guiding regulatory mechanisms to expedite the registration process and shorten the timeframe for placing products in the Thai market.
• Leading the artwork management for new product launches and updated post-approval labelling and package inserts. I served as the focal point of communication and collaborated cross-functionally with local stakeholders and distributors to ensure compliance with regulatory requirements, expedite approvals, reduce time-to-market, and meet FDA grace periods for existing artwork updates.
• Actively monitoring emerging regulatory guidelines and legislation, providing ongoing local regulatory intelligence, and conducting detailed assessments of changes related to specific projects, as well as any shift in the local regulatory environment that could impact the regulatory strategy or plan. Developing scenario and contingency plans to ensure the achievement of results under changing situations.
• Conducting internal audits of the Quality Management System (QMS) and supporting FDA inspections for Good Distribution Practices (GDP) for medical devices and drugs.
• Implementing a pharmacovigilance program that reports adverse events, device defects, FSCA, and annual reports to ensure patient safety and regulatory compliance.
• Supporting the preparation and maintenance of risk management plans (RMP) and performing literature searches to identify and analyze relevant publications.

Managing the preparation and submission of product registrations and amendments, as well as performing quality assurance activities related to pharmaceutical products (antihyperlipidemic). Responsibilities include:
• Overseeing product registration and supporting product launches and tender applications.
• Ensuring regulatory compliance with local regulations and internal procedures.
• Participating in project teams by providing guidance in regulatory affairs expertise and supporting other team members, including those in the marketing department.
• Reviewing technical and quality documents, such as product specifications and analytical methods, and evaluating 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