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Regulatory Officer

Welmark Pharmaceuticals

发布 Nov 15, 2024 412 查看

PKR. 45,000 - 60,000/Month

Regulatory Documentation Management

Prepare, review, and submit regulatory documents for product registrations and variations.
Ensure documentation accuracy and compliance with regulatory standards.
Coordination with Regulatory Authorities
Communicate effectively with regulatory authorities, including DRAP, to facilitate approvals and address queries.
Stay updated on regulatory changes affecting the industry.

Post-Registration Activities

Manage post-registration variations and address deficiencies.
Ensure timely responses to regulatory letters.

Interdepartmental Collaboration

Collaborate with various departments within DRAP and the company.
Ensure smooth communication and regulatory compliance.
Central Research Fund (CRF) Coordination
Coordinate the CRF approval process with DRAP.
Implement strategies to expedite CRF approvals.

Compliance Oversight

Ensure all regulatory activities align with current requirements.
Monitor and maintain regulatory compliance processes.

Technical Skills

Proficiency in DRAP portal operations.

Strong Microsoft Office skills, including Excel and Word.

技能

Time Management Planning and Budgeting Complaint Management MS Excel

工作详细内容

全部职位:

1 发布

工作时间:

早班

工作类型:

全职/长期工

工作地址:

拉瓦尔品, 巴基斯坦

性别:

男性

最低学历:

学士

职位等级:

资深专业人员

电话预约已成功，我们的专家会在短时间内与你联系:

2年

在之前申请:

Dec 01, 2024

发布日期:

Nov 15, 2024

Welmark Pharmaceuticals is an ISO 9001:2015 & 14001:2004 certified manufacturing plant in compliance with the requirements of Current Good Manufacturing Practices (cGMP), Good Laboratory Practices (GLP) and Goods Storage Practices (GSP) to ensure the implementation of Zero Defect Concept. The plant is equipped to provide a healthy, safe and conducive working environment to employees. Welmark brand & product portfolio contains over a hundred offerings quality as per cGMP. The aim of such a wide portfolio in the form of Tablets, capsules, sachets, suspensions and injectable is to satisfy our current & future customers, enabling more people to take charge of their health, meeting their often complex needs. Our ultimate goal is to provide better choices, better health for better lives.