Regulatory Affairs - Africa Markets

Created by: Teva Pharmaceuticals
Added: 29.06.2020

Advert description

Job Description:

Tasks and Responsibilities

  • Support submissions of new product applications in Nigeria and other African markets
  • Ensure the maintenance and update of registrations in accordance with the relevant legislation, regulations and guidelines
  • RA expert, and such be able to identify opportunities and risks
  • Ensure approval of new product submissions and amendments
  • Be the RA focal point for communication with the distributors
  • Review and approval of artwork and printed packaging
  • Establish and maintain effective relationships with all stakeholders
  • Adjust and Establish company SOP’s.
  • Responsible for High level DD of relevant dossiers

Qualifications:

  • B.Pharm degree
  • Minimum 5 years regulatory affairs experience
  • Experience with CTD files, and well understanding of the different modules mainly CMC part
  • Good analytical, organizing and communication skills
  • Self-motivated and proactive
  • Good team player
  • Project management would be advantageous
  • Able to handle multiple projects simultaneously
  • Written and spoken English knowledge.
  • Experience in writing SOP’s and implementing SOP’s would be advantageous

Specific details

Type of Contract Full time, Interim
Preferred Education Bachelor's, Master's, Other
Level of Experience 5-10 years

Location

Israel, Asia
Petaẖ Tiqwa