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Sep 15, 2017

Laborex Senior Regulatory Affairs Officer Job in Kenya

Laborex Kenya Limited, an importation, distribution and marketing of Pharmaceutical Products Company wishes to recruit a Senior Regulatory Affairs Officer for our client Martindale Pharma. 

Martindale Pharma, headquartered in the UK, is a leading international pharmaceutical specialty company.

Key Responsibilities and Qualifications

Reporting to the Head of Regulatory Affairs, the Senior Regulatory Affairs Officer will:
  • Serve as the primary interface within the organization to provide input, coordinate and execute procurement of specialty regulatory documentation and registration sample requests in order to support the registration and maintenance of marketed products in Africa.
  • Prepare all the Module 1 for Regulatory submissions, and by working with cross functional team I partners Module 2, 3, 4 & 5 for the regulatory dossier in ECTD format as required by respective markets.
  • Manage applications to African Regulatory Authorities in a timely manner. This will include:
  1. marketing authorization applications
  2. variations and renewal requests for existing authorizations
  3. answers to questions and post registration! approval submissions
  4. meeting packages for scientific advice and protocol assistance
  5. preparation of product labelling texts and leaflets
  • Identify the gaps between available data and data required to prepare the modules for the regulatory dossier in eCTD format especially module 2 and 3.
  • Develop and deliver core labeling documents such as Summary of Product Characteristics (SM PC) and Patient Information Leaflet (PIL) to support submissions to the Regulatory Authorities across regions
  • Keep up to date with legislation and regulations and provide regulatory input to internal and external business partners
  • Organize and comprehend technical and regulatory data pulled from multiple information sources: having varied levels of difficulty.
The candidate must have a degree in Pharmacy, chemistry or life sciences, Minimum of 5 years Regulatory Affairs experience including the Preparation of modules for the regulatory dossier in eCTD format for new license application submissions, submission of variations and renewals

Knowledge and experience either of Kenyan, Tanzanian, Ghanaian or Ugandan Regulatory authorities would be an added advantage

Email your CV and a cover letter to: [email protected]

Please note:

Only selected candidates will be contacted

Deadline for sending application is 22nd September, 2017

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