Executive – Regulatory Affairs, Shelys Pharmaceuticals Ltd

Job Summary

A client seeks to hire a qualified candidate for the position of an Executive – Regulatory Affairs

  • Qualification Level: Bachelor
  • Experience Level: Mid level
  • Experience Length: 1 year

Job Description

Desired Profile

  • Education: Bachelor of Pharmacy
  • Experience: 0 – 4 years
  • Good knowledge of Microsoft office and databases

Reporting Line

To Head – Quality Assurance

Duties & responsibilities

  • Preparation of product registration dossiers for Tanzania and various other countries as per registration guidelines
  • Review of queries from regulatory agencies and ensure timely response to it
  • Timely submissions of Amendments/Variations/annual updates, Technical Data Package/Open Parts of DMFs responses to regulatory agencies
  • To maintain regulatory database, registrations and compliance to procedures
  • Sound knowledge on WHO, ICH, TFDA and otaer regulatory guidelines
  • Responsible for checking of artworks as per the guidelines
  • Preparation of technical file for tenders (Product Permission, CPPs, FSCs, Product License and other relates documents) as per business plan
  • Any other responsibilities given by the Head of the Department / Management

Interested candidates have to send their application letters, updated CV (including three referees), copies of academic certificates and daytime telephone contact to the undersigned through the address and or email below.

The Senior Human Resources Manager

Shelys Pharmaceuticals Ltd

New Bagamoyo Rd, Mwenge

P.O.Box 32781

Dar es Salaam

[email protected]

Important Note: Women and persons with disability are particularly encouraged to apply.

Applications to reach us on or before 28.02.2018; only shortlisted candidates will be contacted.

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