Executive Regulatory Affairs - 1 Post

Published by Jobstanzania on 2:51:00 pm

Shelys Pharmaceuticals Ltd, a member of the Aspen Group of Companies, is a leading pharmaceutical manufacturing company in East Africa. We are seeking to recruit qualified & experienced individuals for the below positions.

Executive - Regulatory Affairs - 1 Post

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 other 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 I Management.

How To Apply:
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
Nwe Bagamoyo Rd, Mwenge,
P. O. Box 32781
Dar es Salaam


E: info@tz.betashelys.com

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

Applications to reach us on or before 28th February 2018;

Only shortlisted candidates will be contacted

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