เงื่อนไขการค้นหา

ทักษะ:

Problem Solving, English

ประเภทงาน:

งานประจำ

• 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

ประสบการณ์:

2 ปีขึ้นไป

ทักษะ:

Quality Assurance, English

ประเภทงาน:

งานประจำ

• 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.

ทักษะ:

Compliance, Finance, Legal, English

ประเภทงาน:

งานประจำ

• Develops strong site relationships and ensures continuity of site relationships through all.
• phases of the trial..
• Performs clinical study site management/monitoring activities in compliance with ICH-GCP,.
• Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated.
• documents..
• Gains an in-depth understanding of the study protocol and related procedures.
• Coordinates & manages various tasks in collaboration with other sponsor roles to achieve.
• Site Ready..
• Participates & provides inputs on site selection and validation activities.
• Data generated at site are complete, accurate and unbiased.
• Subjects right, safety and well-being are protected.
• Conducts site visits including but not limited to validation visits, initiation visits, monitoring.
• visits, close-out visits and records clear, comprehensive and accurate visit & non-visit.
• contact reports appropriately in a timely manner..
• Collects, reviews, and monitors required regulatory documentation forstudy start-up, study.
• maintenance and study close-out..
• Communicates with Investigators and site staff on issues related to protocol conduct,.
• recruitment, retention, protocol deviations, regulatory documentation, site.
• audits/inspections and overall site performance..
• Identifies, assesses and resolves site performance, quality or compliance problems and.
• escalates per defined CRA Escalation Pathway as appropriate in collaboration with CRA.
• Manager, CRM, TA Head and CRD as needed..
• Works in partnership with GCTO country operations, finance, regulatory affairs,.
• pharmacovigilance, legal and regional operations, HQ functional areas and externally with.
• vendors and IRB/IECs and Regulatory Authorities in support of assigned sites..
• Manages and maintains information and documentation in CTMS, eTMF and various other.
• systems as appropriate and per timelines..
• Supports audit/inspection activities as needed.
• Performs co-monitoring where appropriate.
• Bachelor s degree (or above) in a scientific / healthcare discipline together with at least 6 months of relevant experience in the healthcare field.
• Fluent in Local Languages and English (verbal and written) and excellent communication skills, including the ability to understand technical information. Developing ability to present technical information with support.
• Good understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines.
• Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines.
• Hands on knowledge of Good Documentation Practices.
• Developing skills in Site Management including management of site performance and patient recruitment.
• Developing level of monitoring skill and independent professional judgment.
• Good IT skills (Use of MS office, use of some clinical IT applications on computer, tablet and mobile devices) and ability to adapt to new IT applications on various devices.
• Works with high quality and compliance mindset.
• Capable of managing complex issues, solution-oriented approach.
• Ability to perform root cause analysis and implement preventative and corrective action.
• Effective time management, organizational and interpersonal skills, conflict.
• management..
• Able to work with other experienced research professions to develop skills across multiple protocols, sites and therapy areas.
• High sense of accountability / urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment, with support from Line Manager.
• Works effectively in a matrix multicultural environment. Ability to establish and maintain culturally sensitive working relationships.
• Demonstrates commitment to Customer focus.
• Positive mindset, growth mindset, capable of working independently and being self-driven.
• Demonstrates and projects professional demeanor and communication consistent.
• with organizational policies and practices..
• Accountability, Adverse Event Report, Clinical Evaluation Reports, Clinical Research Methods, Clinical Site Management, Clinical Study Management, Clinical Trial Planning, Clinical Trials, Clinical Trials Monitoring, Data Analysis, Good Clinical Data Management Practice (GCDMP), Investigations Training, Key Stakeholder Relationships, Medical Research, Pharmaceutical Guidelines, Pharmacovigilance, Proper Documentation, Protocol Adherence, Regulatory Affairs Compliance, Regulatory Compliance, Regulatory Documents, Root Cause Analysis (RCA), Site Management, Solution-Oriented, Task Management
• Current Employees apply HERE.
• Current Contingent Workers apply HERE.
• Search Firm Representatives Please Read Carefully
• Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
• Regular
• Hybrid
• 12/19/2025A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
• Requisition ID:R374016.