Our client inthe Medical industry is looking for a Regulatory Affairs Pharmacist to join their organisation.

Responsibilities:

  • Compile and submit new product applications and ensure that the registration requirements are fulfilled so that the registration process and approval can be obtained as soon as possible.
  • Monitor and follow up on the progress of submissions.
  • Activities relating to product lifecycle management.
  • Maintain and develop working relationships effectively and provide required regulatory support.
  • Reviewing artwork relating to products ensuring that it is in compliance with all legal requirements.
  • Checking Format and Content Compliance with latest codes of conduct and regulations.
  • Keeping abreast of developments and changes in the local regulatory environment which directly impacts on the product brands.

Minimum Requirements

  • Bachelor of Pharmacy degree is essential
  • Registration with the South African Pharmacy Council (SAPC) is essential
  • Minimum of 2-4 years Regulatory Affairs experience in pharmaceutical industry.
  • Experience working with SAHPRA and other Regulatory Authorities in Africa.
  • Experience submitting eCTD – good computer literacy skills also required.
  • Hard working – able to multi task and manage multiple projects simultaneously.
  • Strong communication skills – experience in liaising with Business Managers, Quality Assurance & Marketing departments
  • Knowledge of Acts, Regulations and guidelines pertaining to the Pharmaceutical Industry.
  • In-depth knowledge of regulatory requirements.
  • Understanding of regulatory compliance and the impact this can have on the business.
  • Good Understanding of Quality Management Systems, SAHPRA Guidelines and Policies, Medicines and Related substances and regulations, GMP and any other QA/RA related guidelines.

Salary Breakdown:

Basic Salary: Market Related
Medical Aid Company Contribution
Pension Fund Company Contribution

Desired Skills:

  • Regulatory Affairs Pharmacist
  • Bachelor of Pharmacy degree
  • Regulatory Affairs

Desired Work Experience:

  • 2 to 5 years

Desired Qualification Level:

  • Diploma

About The Employer:

Our client is based in North Riding

Employer & Job Benefits:

  • Medical Aid
  • Pension Fund

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