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| Level 4 BEE Rating |
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Johannesburg
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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 |
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| Regulatory Affairs Pharmacist - Branded Generics |
| JHB |
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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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