Regulatory Affairs Scientist

3 days ago

Southern Suburbs Western Cape, South Africa Pharma Dynamics Full time R250 000 - R500 000 per year

ABLE TO UNDERTAKE ALL OF THE RESPONSIBILITIES BELOW

Product / dossier life cycle management

  • Conduct due diligence on received change controls, variation packages, and dossiers pertinent to, but not restricted to, life cycle management of products within the registered SAHPRA portfolio.
  • Compile and submit responses to SAHPRA recommendations, Safety Updates and variations, within agreed and specified time limits, with a focus on allocated phased in approach on complexity of submissions
  • Compilation of dossier modules related to submission of variations and/or SAHPRA responses when not supplied by third party stakeholders.
  • Identify and maintain updates on registered products based on SAHPRA guidelines and allocated priorities.
  • Interact on a regular basis with PD departments, overseas affiliates, third parties and contractors on necessary regulatory activities.
  • Liaise with SAHPRA on behalf of Pharma Dynamics on new and existing queries, as and when required.
  • Assist with maintaining applicant interface of SAHPRA apps (eg. Engagement Portal, NDS), pertaining to life cycle management of products, to streamline departmental workflow.
  • Maintain the department's online apps (eg. CCP database, docuBridge etc) as per official SOPs and/or working instructions.
  • Assistance with the artwork process to finalise printed packaging, as/when required.
  • Supervise/manage/coach staff complement and related activities, if/when necessary.

Technical /Compliance activities

  • Manage and monitor the Change Control Process effectively.
  • Liaise with SAHPRA on registration status and technical queries.
  • Assist with technical queries internally and with the guidance of line management, externally, as/when necessary.
  • Assist in obtaining information pertaining to Pharmacovigilance and Technical queries, as/when necessary.
  • Assists in obtaining information pertaining to batch release queries, as/when necessary.
  • Assists with periodic internal audits, as/when necessary.

Packaging material

  • Review and facilitate approval of printed packaging components as per SAHPRA requirements, on behalf of the division.

Document management

  • Ensure docuBridge is current and up to date and in line with submitted dossiers.
  • Ensure CCP database is aligned to regulatory updates implemented in docuBridge .

General

  • Perform any other duties as per changes in operational requirements of the department.
  • Perform any other duties as requested.

PRE-REQUISITES

  • B.Sc. degree or equivalent scientific qualification.
  • Minimum of 1 - 2 years Regulatory experience in submitting variations to SAHPRA's CEM, PEM and inspectorate units.
  • Experience with eCTD software will be beneficial.
  • Able to perform all standard registration processes under specialist guidance.

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