Level 4 BEE Rating
Johannesburg /
Bloemfontein
+27 (0)11 455 0677 /
+27 (0)11 807 8644
Durban / Western &
Eastern Cape
+27 (0)31 202 4511
Email
stowe@medsearch.co.za
Regulatory Affairs Pharmacist - Branded Generics
JHB
salary

Minimum Requirements:

  • B Pharm or Dip Pharm qualification essential
  • Registration with the South African Pharmacy Council
  • HSA/Quad pharmaceutical registration course (preferable)

Competencies:

  • Minimum 2 - 3 years Regulatory experience in Pharmaceutical aspects of dossier preparation and submission, in a Generic pharmaceutical environment
  • Computer literacy in MS Office suite
  • Excellent written and verbal communication skills
  • Time management and planning skills
  • Strong interpersonal skills with a customer relationship focus
  • Strong negotiation and communication skills with key customers such as the MCC and Global Regulatory Affairs
  • Uncompromosing attention to details and accuracy
  • Drive towards delivery and results
  • Ability to work independently in a highly pressurised environment

Key Performance areas:

  • Initiate and manage the registration process for new product submissions, and maintenance of existing registrations
  • Pro-actively manage Regulatory processes of Key products (new products, line extensions and actively promoted products)
  • Effectively manage allocated projects
  • Consolidate and strengthen Regulatory leadership role and Market Access priorities
  • Drive development of Patient Risk Management plans (PRMP) for new product submissions
  • Prepare, review and adhere to Standard Operating Procedures (SOP's) and local guidelines
  • Maintain administrative stystems e.g. reports, RAD priorities, policies and procedures
  • Establish and maintain customer relationships and stakeholders partnerships
  • Alignment of personal and company values

To apply, submit your CV online (essential: fill in the CV form). For more information contact Rakeeba on 0118078644

 



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