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.

工作详细内容

全部职位:
1 发布
工作时间:
早班
工作类型:
工作地址:
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

· 51-100 员工 - 拉瓦尔品

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