Regulatory Affairs Pharmacist

2 weeks ago

Johannesburg, Gauteng, South Africa MNA Recruitment Full time

A global pharmaceutical company has a vacancy for a Regulatory Affairs Pharmacist to co-ordinate, project control and provide regulatory support for Central, East Africa and Mauritius countries.


Key Responsibilities:

  • Keeping abreast of regulatory requirements in Central, East Africa and Mauritius countries.
  • Ensure the completion of submissions/ variations according to Central, East Africa and Mauritius strategic plan and timelines.
  • Drive registration/variation follow up strategies and find solutions to potential supply challenges.
  • Ensure that labelling for Central, East Africa and Mauritius is complaint with incountry specific requirements.
  • Ensure master product tracker is up to date and accurate at all times. Ensure alignment to all other trackers that are linked to the master.
  • Conduct Due diligence activities
  • Coordinate and compile documentation for submission in Central, East Africa and Mauritius countries (New submissions/variations/RA documents) where required.
  • Liaise and communicate with and support local agent in each country to meet regulatory requirements and timelines.
  • Liaise and communicate with QA, Supply Chain and PV departments to ensure compliance and alignment with the various functions (including samples ordered for renewals, variations, and new submissions).
  • Respond to productspecific queries from Central, East Africa and Mauritius countries where required.
  • Coordinate internal back up and filing (electronic and hard copy) of dossiers and relevant communication.
  • Download information from external portal i.e. Docubridge, sharepoint, wetransfer or regulatory drive.
  • Arrange for translations of overseas documentation if required.
  • Schedule Microsoft team meetings or teleconferences as needed.
  • Conduct training sessions with Central, East Africa and Mauritius Team to ensure quality submissions in line with guidelines and upskilling of team members.
  • Standardize folder structures and save information on NRD
  • Central, East Africa and Mauritius folder.
  • Liaise with principals or the company with regards to outstanding information.
  • Verify documents for completeness and current information.
  • Compile and maintain spreadsheets and status reports as needed and upon request.
  • Compilation of work map trackers to ensure visibility of tasks.
  • Ensure Central, East Africa and Mauritius registrations are renewed in a timeous manner and retention fees are paid as required.
  • Assist with task risk management and compilation of risk plans when associated with submissions.
  • Ensure the completion of all assigned Company training within the specified timelines.
  • Forward all received Product Quality Complaints, Adverse Events and Medical Enquiries to the relevant person in Quality Assurance/ Pharmacovigilance/ Medical Affairs

Requirements:

  • Must have a completed Bachelor of Pharmacy Degree and/or equivalent.
  • 35 years' experience in pharmaceutical industry (Regulatory Affairs/ Quality/ Production).
  • Should have a sound knowledge of Sub-Saharan countries regulatory requirements and guidelines.
  • Must have experience and understanding of electronic document management systems / eCTD.
  • High level Computer literacy.
  • People skills highly adapted interpersonal skills.
  • Problem solving analysis skills.
  • Priority setting initiative and follow through.
  • Time management and ability to selfmotivate.
  • Strong attention to detail.
  • Ability to work under pressure.
  • Embodies Values & Behaviours in all internal and external interactions

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