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Skills:

Problem Solving, English

Job type:

Full-time

• Leads Regulatory Affairs function for regulatory compliance in healthcare business.
• Provides regulatory strategic directions and solutions for regulatory affairs.
• General Responsibilities.
• Develop, communicate and implement the strategic direction of the operation and also coordinates all presentations, inquiries and responses involving federal and state regulatory and legislative groups.
• Liaise with government to ensure business meet regulatory compliances.
• Give full accountability for the function and provide the highest level of advice and recommendations on company regulatory and quality compliance.
• Ensure the regulatory affairs activities are conducted accurately, ethically, and according to relevant regulations, laws, and standards.
• Support subordinate to develop SOP/WI/SD for regulatory affairs, pharmacovigilance and other relevant functions.
• Establish and maintain positive relationships with government agencies and other regulatory authorities and network/associations ; represent the organization before in matters regulatory, legislative, or industry standards agencies so that the organization s interests are advanced.
• Assure all audits meet organization and government standards on products/processes. Consults related ongoing issues with the executive leadership team and make decision from management team.
• Risk Management - Monitor and provide regulatory risk analysis or completion of regulatory requirement to meet TFDA regulation. - Manage risk management or required document of client product agreed with client requirement/ PV agreement.
• Functional Skills and Knowledge.
• Regulatory Expertise.
• English Proficiency.
• Problem solving.
• Time managemen.
• Education.
• Bachelor s Degree in Pharmacy or Science or related health product field.
• Minimum 10 years of experience in regulatory affairs career.
• Requisition Number: 214636 Job Function: Regulatory Services

Experience:

2 years required

Skills:

Quality Assurance, English

Job type:

Full-time

• Handle regulatory submission of new product, existing product by working with FDA, Marketing and Supply Chain team.
• Compile dossiers for product registration and renewing of product licenses on a regular basis.
• Prepare and submit regulatory notifications and registrations as required by the company s standards to ensure compliance and timely approval for market release of new and existing products.
• Oversee processes involved with maintaining annual licenses, registrations, and listings.
• Monitor and keep up to date with changes in relevant regulatory legislation and guidelines that may impact products and business strategies.
• Arrange and update packaging artworks of registered products.
• Liaise with the regulatory authorities to obtain registration certificate approval or amendment approval.
• Liaise with the regulatory authority as well as overseas counterparts regards to regulatory affairs matters, including product registrations, variations to existing products and renewals.
• Support logistics function regarding import products.
• Answer inquiries regarding shipping regulations, correct product labeling, saleable product locations and promote good compliance practice.
• Monitor post-market vigilance issues and take role in risk management/assessment.
• Provide advice and advance warning on potential regulatory risks and proposing preventive or corrective measures accordingly.
• Keep updated with FDA regulations and potential changes that will impact the business and advise the appropriate action plans.
• Perform ad-hoc duties as assigned.
• Bachelor s degree or Master s Degree in Pharmaceutical Science or Science.
• Minimum 2 years of experience in cosmetics regulatory affairs.
• Experience in cosmetics, beauty, skin care regulation is a plus.
• Solid knowledge of Cosmetic Products Control in Thailand Guidelines and ASEAN Cosmetic Directive (ACD).
• Excellent time management and interpersonal skills.
• Good command in English.