Regulatory Affairs Pharmacist

Location: Crown Mines, Johannesburg, Gauteng, South Africa
Date Posted: 21-08-2017
Based in Crown Mines, our client is seeking an RA Pharmacist.

EDUCATION
  • Matriculation exemption.
  • B.Pharm Degree.

DESIRABLE SKILLS & EXPERIENCE:

  • 3 years experience in Regulatory Affairs and Production.
 
SKILLS/PHYSICAL COMPETENCIES
  • Good understanding of Microsoft Office/Outlook
 
Company Compliance:
  • To ensure approval of printed packaging material and promotional marketing material.
  • Ensuring compliance with marketing product claims using regulatory expertise.
  • Liaising with marketing department to facilitate timeous launch of products.
  • Responsible for SOP implementation/review, update and compliance.
Product Registration:
  • Liaise with business development for regulatory requirements prior to dossier acquisition.
  • Responsible for anticipating, receiving and submission of new product registrations for a particular financial year. 
  • Responsible for submission of generic dossiers, NCE’s as well as complimentary medicines.
  • Ensure on-going regulatory compliance of the existing product portfolio.
  • Ensure awareness of legislative changes and trends that will impact the core function of the regulatory affairs department and hence the marketability of company products.
  • Ensuring that the company is aware of significant local regulatory issues which can impact the business.
Documentation management:
  • Managing and maintaining regulatory documentation filing system.
  • Ensuring regulatory compliance and quality related records are available and retained.
MCC Submissions:
  • Responsible for new product applications.
  • Manage Post –Registration amendments to ensure dossier compliance.
  • Responsible for Committee recommendation responses to ensure product registration.
  • Responsible for dossier updates to ensure compliance with current legislation.
Pharmacovigilance:
  • Responsible for Pharmacovigilance monitoring within the group
Other
  • Providing status reports to the regulatory department head on the status of projects currently worked on.
 
BEHAVIOURAL QUALITIES
  • Takes ownership.
  • Integrity, bound to principles, confidentiality and ethics.
  • Strong leadership skills.

 

Kind regards / Groete
Erma
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ERMA DAVENPORT | Cell (+27) 082 882 3762  | F  (+27) 0866 000 516  | Skype Erma347_d |
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