Total 5 student affairs director job vacancies in johor

Job Responsibilities:

1. Prepare and compile registration dossiers (data, applications of certifications or others as indicated) for review and checked by superior.

2. To apply for Certificates of Pharmaceutical Product/Good Manufacturing

3. Practice/Indication from local Authority arrange for notarization, legalization and certification of documents by the Notary Public and Embassy of country as needed.

4. To perform preliminary review and check of Artwork materials generated for use in submissions (new product, variation, renewal) with reference to stipulated label requirements of the respective country of export and import.

5. To follow up ongoing task, registration projects proactively with effective communication (by team call, drafting letter, email with the respective project stakeholders.

6. To apply drug product registration renewal, variation as needed.

7. To apply and maintain Pharmaceutical Manufacturing License and Import License renewal of and update certificates- to Purchasing and Shipping Departments.

8. To keep track the validity GDPMD certification for Medical Device and update database Medcast as needed.

9. To track, highlight and update any significant (minor/major) developments of registration projects in the ongoing manner to the superior and to summarize progress in monthly regulatory reports, tracking logs, etc.

10. To liaise with local Authority related to regulatory affairs.
Any other project/assignment that will be advised / directed by the superior.

Requirements:

Possess a Bachelor Degree in Science
Administrative experience in legal/regulatory work functions. 
Good skills in documentation and communication team spirit.
Job Type: Full-time
Salary: RM3,000.00 - RM4,500.00 per month
Schedule:

Monday to Friday
 

Supplemental pay types:

Yearly bonus
 
Ability to Commute:

Senai (Required)
 

Ability to Relocate:

Senai: Relocate before starting work (Required)
 

Perks & Benefits

• Bonus
• Allowance (transportation, etc.)

Job 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 to submission, incorporate feedback from relevant stakeholders.

  • Conduct checks on artworks to ensure in compliance with local regulation.

• Submit product registration applications to local health authorities  according to target submission timelines.
• Liase with and respond to additional requests or queries from health authorities and follow up (when necessary) until approval per target timelines.
• Liase with enternal and external stakeholders/ departments to build rapport and to achieve target outcomes.

2. Comply with regulatory requirements: to maintain validity of existing licenses/ certification/ authorization (e.g, product licenses, manufacturing licenses, establishment license, GDPMD licenses, import/ export license) through timely variations and/ or renewals to ensure supply continuity.

3. Keep abreast of regulatory updates from health authorities in the drugs, cosmetics, and medical device space.

• Assess regulatory updates on impact to business and communicate insights on approach to handle affairs.
• Propose solutions to arising issues.

4. Update and maintain database of regulatory and product registration information.

5. Good maintenance of final submitted documentation and local repository.

6. Ensure compliance with quality procedures stipulated for regulatory affairs, its administartive maintenance, and plan/ suggest improvements to operations.

7. Support any audits or inspections.

8. Guide/ oversee work performance and development of direct report.

9. Provide input for periodic operation metrics/ budget initiatives by managing  operating expenses within approved budget for the year.

10. Handle any other assingment as advised by supervisor.

Requirements: 

• Possess a Bachelor Science
• Work experience in regulatory affairs.
• Familiar with drugs/ cosmetics/ medical device regulatory landscape and GxP related matters.
• Proficiency in Microsoft Office Applications and relevant regulatory system software.
• Adopt good practices in documentation and communication.

Perks & Benefits

• Allowance ( mileage,transportation)
• Medical insurance

工作職責：

1. 準備並編制註冊檔案（資料、認證申請或其他指定內容）以供上級審核和檢查。

2. 申請藥品/良好製造證書

3. 地方當局的做法/指示根據需要安排由公證人和所在國大使館對文件進行公證、合法化和認證。

4. 根據各自出口國和進口國規定的標籤要求，對提交（新產品、變體、更新）所產生的藝術品材料進行初步審查和檢查。

5. 為了跟進正在進行的任務，透過與各自專案利害關係人的有效溝通（透過團隊電話、起草信件、電子郵件）主動註冊專案。

6.根據需要申請藥品註冊延續、變更。

7. 向採購和運輸部門申請和維護藥品生產許可證和進口許可證的更新和更新證書。

8. 追蹤醫療器材GDPMD認證的有效性並根據需要更新資料庫Medcast。

9. 向上級持續追蹤、強調和更新註冊項目的任何重大（次要/重大）進展，並在月度監管報告、追蹤日誌等中總結進展。

10. 與地方當局聯絡有關監管事務。
由上級建議/指導的任何其他項目/任務。

要求：

擁有理學士學位
法律/監理工作職能的行政經驗。
良好的文件能力和溝通團隊精神。
工作類型：全職
薪水：每月 RM3,000.00 - RM4,500.00
日程：

星期一到星期五

補充工資類型：

年度獎金

通勤能力：

士乃 (必填)

搬遷能力：

士乃：開始工作前搬遷（必備）

津貼和福利

• 獎金
• 津貼（交通等）

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。

• 根據目標提交時間表向當地衛生部門提交產品註冊申請。
• 與衛生當局聯絡並回應其他請求或詢問，並跟進（必要時）直至按照目標時間表獲得批准。
• 與內部和外部利害關係人/部門聯絡，建立融洽關係並實現目標成果。

2. 遵守監管要求：透過及時變更和/或更新來維持現有許可證/認證/授權（例如產品許可證、製造許可證、企業許可證、GDPMD許可證、進出口許可證）的有效性，以確保供應連續性。

3. 隨時了解衛生當局在藥品、化妝品和醫療器材領域的最新監管動態。

• 評估監管更新對業務的影響，並就處理事務的方法傳達見解。
• 針對出現的問題提出解決方案。

4.更新和維護監管和產品註冊資訊資料庫。

5. 妥善維護最終提交的文件和本機儲存庫。

6. 確保遵守監管事務、行政維護規定的品質程序，並規劃/建議營運改善。

7. 支持任何審計或檢查。

8. 指導/監督工作績效和直接報告的發展。

9. 透過在年度核准的預算內管理營運費用，為定期營運指標/預算計畫提供輸入。

10. 處理主管建議的任何其他分配。

要求：

• 擁有科學學士學位
• 監管事務方面的工作經驗。
• 熟悉藥品/化妝品/醫療器材監管環境和 GxP 相關事宜。
• 熟練Microsoft Office應用程式和相關監管系統軟體。
• 在文件和溝通方面採用良好的做法。

津貼和福利

• 津貼（里程、交通）
• 醫療保險

職責：

• 協助會計部成員履行職責。
• 協助歸檔、資料輸入以及維護準確完整的財務記錄。
• 誠實正直地處理敏感或機密資訊。
• 支援一般管理任務，包括文件歸檔、電話接聽和電子郵件回覆。

津貼和福利

• 休閒著裝要求
• 開放文化
• 個人發展機會
• 加班可申請索賠