Regulatory Scientist

2 weeks ago

Cape Town, Western Cape, South Africa Clicks Group Limited Full time

Advert reference:
click_012750

Advert status:
Online

-
Position Summary:

Industry:
Wholesale & Retail Trade

Job category:
Pharmaceutic

Location:
Cape Town

Contract:
Permanent

Remuneration:
Market related

EE position:
Yes

Brand:
Clicks Group

Introduction:


We are looking for a Regulatory Scientist to take up an exciting opportunity within our Unicorn Pharmaceutical division within Clicks.

This role reports to the Regulatory Pharmacist and will be based at our Head Office in Cape Town.

Job description:

Purpose:


To administer the life cycle of medicinal products, medical devices and IVD's for allocated therapeutic categories, including liaison with relevant stakeholders such as Health Authorities, third parties and internal stakeholders.


Job Objectives:

  • Product Registration and Dossier Maintenance
  • Conduct due diligence on all Unicorn dossiers from overseas and local suppliers and compile for submission in South Africa and neighbouring countries
  • Compile and submit all required dossier variations as per current SAHPRA guidelines and guidelines of neighbouring countries
  • Identify and maintain updates on existing products based on SAHPRA guidelines and the guidelines of neighbouring countries and allocated priorities
  • Interact on a regular basis with overseas affiliates, third parties and contractors on dossier related activities
  • Compile and submit all SAHPRA and other Regulatory Authorities' recommendations within agreed and specified time limits
  • Compile and submit all SAHPRA and other Regulatory Authorities' SmPC and Patient Information Leaflet safety updates within agreed and specified time limits
  • Compile and submit all product variations within agreed and specified time limits
  • Conduct the transfers of applicant of registered dossiers to Unicorn
  • Complete and submit all official SAHPRA and other Regulatory Authorities' official templates in support of new dossier and variation submissions
  • Ensure eCTD compliant document management, hyperlinking, and validation
  • Perform peer quality reviews
  • Perform general management of all documentation in the format as prescribed by SAHPRA and other Regulatory Authorities' guidelines
  • Coordinate with Unicorn suppliers, manufacturers, and external regulatory consultants to ensure resolution of Regulatory Authority queries and technical matters, maintaining variation schedules, obtaining master documentation to facilitate compilation, submission, and approval by the regulatory authorities
  • Complete CTD conversions as per allocated timetable and ensure product dossiers are maintained and updated on the electronic database and paper copies are available for inspection
Packaging and Marketing Materials

  • Review and assist with the approval of printed packaging components and promotional material.
  • Assist with compilation, review, and approval of advertising/marketing material
  • Ensure that all printed material (including web based) complies with the Marketing Code of Conduct and SAHPRA and other Regulatory Authorities' requirements
Technical/ Compliance Activities

  • Assist with annual product reviews
  • Assist with technical queries internally and externally
  • Assist with answering relevant Patient, Pharmacovigilance and Technical queries under the supervision of a pharmacist
  • Assist in the compilation, review and updating of relevant SOPs
  • Assist with the review and approval of Batch Release documents
  • Assists in Periodic internal audits
  • Manage and monitor the Change Control Process effectively
  • Frequently communicate all product life cycle matters to the Quality Assurance Manager, as per internal processes and documentation
Document Management

  • Ensure the EDMS is current and up to date and in line with printed dossiers.
  • Ensure dossiers are in line with SAHPRA requirements and assist with the maintenance thereof and preparations for eCTDsubmissions (baseline dossiers)
General

  • Perform any other duties as per changes in operational requirements of the Scientific Affairs department to ensure Regulatory compliance.
  • Perform any other regulatoryrelated duties which may be requested by management and/or other departments for the success of Unicorn
  • Keep abreast of new pharmaceutical and regulatory trends (dosage forms, active ingredients, regulatory changes) across the industry.

Minimum requirements:

Job related knowledge:

  • Knowledge of the generic pharmaceutical market
  • Knowledge of registrations in South Africa and other African countries
  • Knowledge and understanding of pharmaceutical industry laws, regulations, guidelines, and ethics (Medicine Act and Regulations to the Act, Pharmacy Act and Regulations to the Act, Foodstuffs, Cosmetics and Disinfectants Act, Marketing Code)
  • Other Industry related laws, regulations, and ethics (CPA, Companies and Competition Acts and POPIA)
  • SAHPRA submission codes
  • Business processes
  • Knowledge of Pharmaceutical R&D, Manufactur

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