Regulatory Affairs Pharmacist - Midrand, South Africa - Cipla

Cipla
Cipla
Verified Company
Midrand, South Africa

1 month ago

Thabo Mthembu

Posted by:

Thabo Mthembu

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Description

Department:

Regulatory Affairs


Job Purpose:


Accountabilities:


  • CDT/New dossier submissions and approvals
  • Perform prelaunch activities to ensure timeous submission and registration of products within the defined timelines.
  • Dossier Life Cycle Management
  • Perform the dossier life cycle management activities by supporting the post registration variations and other activities to ensure support to the regulatory function and its objectives.
  • Support and assist the administrative team in the responsibility to effectively manage and maintain dossiers (electronically and hard copies), collection and delivery of documents, ensure smooth operations and maintain quality standards.
  • Develop and manage stakeholder relationships by communicating and interacting on a regular basis in order to achieve the functional objectives.

A detailed job description can be made available on request

Education Qualification:

B Pharm Degree


Relevant Work Experience:

Minimum 2 years of experience in the regulatory function covering all areas, Attention to detail, Resilience, Collaborative approach, time-management, good communication skills, team player & experience in e-CTD submissions


Competencies/Skills:


  • Innovation Driven
  • Purpose Inspired
  • Integrity and Trust Anchored
  • Responsibility Centered
  • Excellence Focused
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