Regulatory Officer

Listing reference: 020238 Listing status: Online Apply by: 15 June 2025

Position summary

Industry: Pharmaceutical Sector Job category: FMCG, Retail, Wholesale and Supply Chain Location: Cape Town Contract: Permanent Remuneration: Market Related EE position: Yes

About our company

Clicks Group

Introduction

The Clicks Group is looking to recruit a Regulatory Officer to work within our UniPharma division, the role is based at the Clicks Head Office and will report into the Regulatory Manager

Job description

Job Purpose

• Ensure that all the tasks related to the compilation and accurate delivery of all printed material, ensuring Legal, Regulatory and Marketing Code compliance and successful Product Launches for all Marketing & Distribution Partners (M&D Partners).
• Ensure the monitoring and reporting of any product complaint, including technical/quality and pharmacological (adverse drug reactions and adverse events) complaints of all products of M&D Partners marketed and commercialised through the Clicks Retailers channels, to the relevant M&D partner.

Job Objectives

• To liaise with the Clicks in-house advertising agency (BTB) and Marketing & Distribution Partners and their Suppliers / Manufactures to ensure timeous compilation and accurate delivery of all printed material, ensuring accurate compilation and proofreading of all PIs, PILs and product packaging artwork according to prescribed SOPs to ensure legal regulatory and marketing code compliance for all such partners and as detailed in the relevant Technical Quality Agreements (TQAs) with such partners.
• To timeously deliver regulatory compliant marketing, promotional and/or educational material required through effective communication and proactively managing and ensuring delivery with all stakeholders effectively utilising and coordinating logistics and resources.
• To liaise with multiple stakeholders to ensure products are listed on all applicable internal and external IT systems according to project deadlines.
• To create and manage project management tools (trackers) ensuring accurate and timely delivery on commercial expectations.
• To apply good document management practices to ensure regulatory legal compliance (e.g. traceability and version control.
• To keep all filing of advertising and marketing (printed) material up to date.
• To keep abreast of new pharmaceutical and regulatory trends, specifically pertaining to advertising and marketing (printed) material intended for use by healthcare professionals as well as patients and caregivers.
• To collect, evaluate and record technical product complaints and communicate such events to the relevant M&D Partner.
• To collect, evaluate and record pharmacological product complaints (Adverse Drug Reactions [ADRs] and Adverse Events [AEs] and communicate such events to the relevant M&D Partner.
• Communicate weekly (Adverse Drug Reactions [ADRs] and Adverse Events [AEs] to M&D Partners.
• Submit monthly (Adverse Drug Reactions [ADRs] and Adverse Events [AEs] reconciliation reports to M&D Partners.
• Any other duties as per changes in operational requirements of the department to deliver Regulatory compliance.

Minimum requirements

JOB RELATED KNOWLEDGE

• Pharmaceutical industry laws, regulations and ethics (Medicines and Pharmacy Acts)
• Marketing code related to pharmaceutical industry
• Other Industry related laws, regulations and ethics (CPA, Companies and Competition Acts)
• Business processes pertaining to development of Promotional material, New Launch Activities, Purchase orders and stock control
• Knowledge of Pharmaceutical Manufacturing, Wholesaling/Distribution
• Knowledge of GWP/GDP/GMP
• Solid knowledge of Pharmacovigilance processes

JOB RELATED SKILLS

• Verbal and written communication
• Problem solving and analytical thinking
• Attention to detail
• Ability to keep meticulous records
• Ability to interact and communicate effectively with a wide range of people
• Relationship building skills
• A systematic approach to tasks
• Excellent IT skills (Microsoft suite)
• Good interpretative skills
• Teamwork
• Project management, planning and organising skills
• Record keeping and document administration skills
• Policy and procedure development skills
• Analytical and problem-solving skills
• Presentation skills

JOB EXPERIENCE

• At least 3 years working experience in a quality environment within the pharmaceutical industry
• At least 1 year Pharmacovigilance experience.

EDUCATION

• Relevant Bachelors degree, or

• Equivalent National Diploma (a 3-year qualification) in Life sciences, Biotechnology, Chemistry etc.)Relevant Bachelors degree

JOB RELATED COMPETENCIES

• Deciding and Initiating Action
• Working with People
• Adhering to Principle and Values
• Relating and Networking
• Writing and Reporting
• Planning and Organising
• Following Instructions and Procedures
• Adapting and Responding to Change

Information :

• Company : Clicks Group Limited
• Position : Regulatory Officer
• Location : Cape Town, Western Cape
• Country : ZA