Regulatory Affairs Manager

Responsibilities:1.New product registration:Prepare and compile registration dossiers in accordance with relevant regulatory requirements including:Constructing/ editing letters of response/ justification/ declaration and clinical documentation for submission packages in accordance with guidelines checklists. Compile/ review/check material for dossier prior...

Objective: Responsible for the management of regulatory submissions for new product registration as well as the notification of change of existing products registered in the APAC, European and US region, whilst ensuring compliance with the relevant legislation, industry standards and Company policies. Key Responsibilities: - Manage independently all...

Position Overview:Responsibilities:- Regulatory Compliance: Stay abreast of local and international regulatory requirements related to the project. Monitor changes in regulations and communicate updates to relevant stakeholders. Assist in developing projectspecific strategies to ensure ongoing compliance with regulatory standards.- Documentation and...

Objective:Responsible for the management of regulatory submissions for new product registration as well as the notification of change of existing products registered in the APAC, European and US region, whilst ensuring compliance with the relevant legislation, industry standards and Company policies.Key Responsibilities: Manage independently all government...

**Position Overview**: **Responsibilities**: - **Regulatory Compliance**: - Stay abreast of local and international regulatory requirements related to the project. - Monitor changes in regulations and communicate updates to relevant stakeholders. - Assist in developing project-specific strategies to ensure ongoing compliance with regulatory standards. -...

**Position Overview**: **Responsibilities**: - **Regulatory Compliance**: - Stay abreast of local and international regulatory requirements related to the project. - Monitor changes in regulations and communicate updates to relevant stakeholders. - Assist in developing project-specific strategies to ensure ongoing compliance with regulatory standards. -...

**Position Overview**: **Responsibilities**: - **Regulatory Compliance**: - Stay abreast of local and international regulatory requirements related to the project. - Monitor changes in regulations and communicate updates to relevant stakeholders. - Assist in developing project-specific strategies to ensure ongoing compliance with regulatory standards. -...

**Roles and Responsibilities** - Support regulatory compliance advisors in Therapeutic & Health Products, projects. Projects activities include: 1. Reviewing product technical documentation or technical file preparation on therapeutic and health products. 2. Product registration with country dossier preparation from the product technical documentation &...

**JOB RESPONSIBILITIES** - To monitor and ensure company products and processes adhere to regulatory requirements by relevant government bodies and international standards. - To oversee and coordinate activities related to product labelling, content and security. - To identify and provide input on the impact of changes in regulations. **JOB REQUIREMENTS** -...

JOB RESPONSIBILITIES To monitor and ensure company products and processes adhere to regulatory requirements by relevant government bodies and international standards. To oversee and coordinate activities related to product labelling, content and security. To identify and provide input on the impact of changes in regulations.JOB REQUIREMENTS Bachelor's Degree...

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through...

**工作職責:****1、新產品註冊:**- 根據相關監管要求準備和編制註冊檔案,包括:- 根據指南清單建立/編輯提交包的回應/理由/聲明和臨床文件。- 在提交之前編譯/審查/檢查檔案資料,納入相關利害關係人的回饋。- 對藝術品進行檢查,以確保符合當地法規。-...

To oversees a company's administrative operations, ensuring efficiency and smooth workflow. Manage inventory of office supplies, PPE, and the purchasing of material with attention to budgetary constraints. Manage total group overall procurement functions such as sourcing quotations, compare pricing, purchase orders and GRN issuance. Manage group insurance...

Oversee day-to-day office operations. - Lead and manage administrative staff. - Manage office space, maintenance, and vendor relationships. - Plan and organize corporate events and meetings. - Facilitate employee travel arrangements. - Ensure compliance with travel policies. - Establish and maintain efficient filing systems. - Safeguard confidentiality and...

To oversees a company's administrative operations, ensuring efficiency and smooth workflow. - Manage inventory of office supplies, PPE, and the purchasing of material with attention to budgetary constraints. - Manage total group overall procurement functions such as sourcing quotations, compare pricing, purchase orders and GRN issuance. - Manage group...

To oversees a company's administrative operations, ensuring efficiency and smooth workflow. - Manage inventory of office supplies, PPE, and the purchasing of material with attention to budgetary constraints. - Manage total group overall procurement functions such as sourcing quotations, compare pricing, purchase orders and GRN issuance. - Manage group...

To oversees a company's administrative operations, ensuring efficiency and smooth workflow. - Manage inventory of office supplies, PPE, and the purchasing of material with attention to budgetary constraints. - Manage total group overall procurement functions such as sourcing quotations, compare pricing, purchase orders and GRN issuance. - Manage group...

Develop, implement, and maintain a robust quality management system in accordance with industry standards and regulatory requirements. - Identify opportunities for process improvements and lead initiatives to enhance efficiency and effectiveness. - Foster a culture of quality, accountability, and continuous improvement within the organization. Compliance and...

**Roles and Responsibilities** 1.Support the senior engineers, quality, and regulatory compliance advisors in Medtech projects. Project such as: - Product technical documentation or technical file preparation on medical device such as engineering testing report, engineering product specifications, harmonised standards on the relevant medical device safety...

**Job Summary: The Quality Manager in the field of Medical Manufacturing plays a critical role in ensuring the highest standards of quality, compliance, and regulatory adherence across all aspects of the manufacturing process. This leadership position requires expertise in quality management systems, regulatory requirements, and continuous improvement...