RA GDD Manager at CDL Human Resource

CDL was founded in early 2003 by its current Managing Director Lucy Mmari.Within her 14 year tenure in a well established logistics company, She honed her skill in human resources management and thereafter started CDL.

 

RA GDD Manager

  • Job TypeFull Time
  • QualificationBA/BSc/HND
  • Experience3 - 5 years
  • LocationNairobi
  • Job FieldPharmaceutical  , Science 

Job Purpose

  • Registration of new drug products and maintenance of approved drug licenses to ensure availability of these products in the countries.
  • Maintain good relationship with the HA to enhance prompt registration of new products and maintenance of product licenses. 
  • Maintain all necessary organization databases (e.g. DRAGON) to always ensure regulatory compliance.
  • Maintain open communication with the different stakeholders and regularly provide information when required.
  • Liaison between different stakeholders on regulatory matters.

Major Accountabilities

  • To support the planning and co-ordination of submission of drug registration applications in a timely manner and follow through the application during the evaluation phase to achieve approval in line with planned registration timelines.
  • To ensure (through follow up) that documents for new registration and re­registration are requested and received to ensure submission is achieved by due dates
  • To ensure that submissions for license renewal are done in good time before license expiry to achieve approvals and to avoid Top line impact due to license expiry
  • To ensure submissions for production transfers and pack size extension are made and approvals received by due dates
  • To apply for and get approvals for pre-license promotion through named patient basis or orphan drugs when required.
  • Ensure compliance to current local regulations and communication of any changes that may impact our organization in a timely manner to all relevant Stakeholders.
  • Support the update local/Regional Working Practices or SOPs when required.
  • Ensure adherence to Global and local/regional processes.
  • Ensure prompt submission of post approval commitments, PSUR submissions, RMP submissions, SLC updates and ensure timely responses to HA as required.
  • Ensure issues of non-compliance are handled with urgency and appropriate channels are engaged in a timely manner when necessary
  • Ensure compliance to global and local KPIs.
  • Review and approval of marketing promotional materials when assigned by RA Head
  • Develop and maintain good working relationships with other organizations functions/departments both locally and globally, as well as with health authority, local technical representatives and industry bodies.
  • Support our LTRs and distributors on regulatory issues as assigned by RA Head
  • Support the organization culture including promotion of diverse and inclusive environment, free from all forms of discrimination and harassment

Requirements

Ideal Background

  • Education (minimum/desirable): B. Pharm or BSc 
  • Languages: Fluent in English (mandatory)
  • Experience: Minimum 3-5 years regulatory and drug/biologics development experience.
  • Health Authority experience desirable in Ethiopia and Sudan
  • Good communication and negotiation skills.
  • Good inter-personal skills.

Method of Application

Interested and qualified? Go to CDL Human Resource on cdl.zohorecruit.com to apply

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