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YOUR TASKS AND RESPONSIBILITIES

Provide strategic regulatory direction on the overall regulatory plan, regulatory requirements for clinical studies and marketing approval, risk assessments, critical issue management. Ensure successful implementation and execution of regulatory plans to support product approval and commercialization
Managerial responsibility of RA Thailand cluster, including talent management and people development, succession planning:
o Identifies resource requirements and allocates resources to meet regulatory needs. Ensures early identification of conflicts between projects and ensures transparent and aligned prioritization. Budget owner of RA Thailand cluster
o Responsible for the preparation of local budgets and the optimal hiring and training of staff.
o Guide and direct the RA Thailand cluster organization for ensuring RA processes and systems are effectively implemented, maintained and utilized. Continuously identifies and implements efficiency, productivity goals for integrated RA organization (resources, processes, systems).
o Ensures the preparation of the application files for products based on the documentation provided from RA Regulatory Partners in accordance with local regulations, is of acceptable standard and quality for the respective authorities.
o Where applicable, ensures the preparation of the application files for clinical trials, based on the documentation provided from RA Regulatory Partners, are in accordance with the local regulations and presents them to the respective authorities, where locally relevant.
o Guide, coach and manage a team of regulatory professionals to ensure their professional development and advancement.
Supports the LQR to plan, manage GMP inspection requirements incuding GMP applications, inspections and certifications of the manufacturing sites as locally relevant. Work closely with LQR to provide regulatory expert input to manage product complaints and recall process, including health authority interaction and communications. Provide necessary functional input and documents to enable LQR to complete local compliance checks and develop local QSD process.
Regulatory quality management: responsible for local and internal compliance to regulatory affairs relevant processes and systems, creation and maintenance of a local quality system including archiving, contact reporting, maintenance of regulatory tracking database and tracking of documents submitted. Manages training and audits of the quality system
Ensures regulatory compliance for a sustainable life-cycle management: Labelling and CMC changes are performed in accordance with local regulations and relevant Bayer SOPs
Responsible to represent PH as a competent reliable partner to the local Health Authorities in all regulatory matters, to enable timely approvals with optimal labels. Establish, maintain and drive external contacts, networks, partnerships and both-ways communication with national regulators, local industry organizations, key opinion leaders and other external stakeholders to proactively shape the regulatory environment in the country. Identify best options and opportunities for business and to pre-empt business issues. Ensures appropriate representation of Bayer in the local industry associations. Oversees communication with Health Authority to ensure Bayer one voice policy.
Provides local RA intelligence: Identifies current and emerging national regulations which impact the drug development and / or marketing processes and ensures appropriate contribution and communication with all involved areas. Contributes actively to design and assessment of RA strategic options as a member of regional regulatory teams. Track regulatory updates that affect Bayer portfolio and translate regulations into opportunities for Bayer.
Partners with regional PH regulatory head to ensure alignment of RA Thailand cluster direction and vision is aligned with overarching global vision and direction
Provision of CPP, GMP certificates and other regulatory documents as needed by Bayer countries using Thailand cluster as reference countries for their product registration.