Regulatory Affairs Portfolio Lead

Jordan Human Resources; Johannesburg; On-site; ZAR 400 000 - 500 000; Full time

Job summary

An established industry player in the pharmaceutical sector is seeking a Regulatory Affairs Portfolio Lead to enhance their Regulatory Affairs team. This role involves managing a portfolio of product outputs, ensuring compliance with the Medicines and Related Substances Control Act, and collaborating with various departments and external partners. The ideal candidate will possess a Bachelor's degree in Pharmacy and have at least three years of experience in Regulatory Affairs, particularly with human medicines. If you are passionate about regulatory processes and thrive in a dynamic environment, this opportunity is perfect for you.

Qualifications

• 3 years of experience in Regulatory Affairs, preferably in human medicines.
• Experience in quality-driven processes and risk management.

Responsibilities

• Support the Regulatory Affairs team to provide superior services.
• Ensure compliance with regulatory authorities and manage product outputs.

Skills

Regulatory Affairs

Risk Management

Change Control

Systems Analysis

Complex Problem Solving

Strategic Thinking

Customer Relationship Management

Education

Bachelor’s degree in Pharmacy

Diploma in Pharmacy

Tools

CTD Software Builder

Job description

A pharmaceutical client is looking for a Regulatory Affairs Portfolio Lead to support the Regulatory Affairs team to provide superior Regulatory services to relevant departments within the company and with external Partners and Principals, and to control and manage a portfolio of product outputs. To ensure legal and regulatory compliance with the relevant medicine Regulatory Authorities (Country Specific where applicable), Medicines and Related Substances Control Act and South African Pharmacy Council, ensuring timeous processing of regulatory applications.

Qualifications

• Bachelor’s degree in pharmacy/Diploma in Pharmacy and Registration with the South African Pharmacy Council

Required experience

• 3 years’ experience in Regulatory Affairs, preferably in human medicines with experience across product development, commercialisation and maintenance lifecycle
• Experience in quality driven processes such as risk management, change control, deviations, CAPA’s, Root cause investigations
• Additional experience in African territories is preferable.

Core competencies

• Experience in use of CTD software builder and compilation of eCTD applications.
• IT skills
• Ability to prioritise and work to tight deadlines
• Systems and operations analysis
• Basic cost management skills
• Active learning
• Strategic thinking
• Ability to cope with a high degree of complexity and change
• Cross Functional skills: Ability to network, liaise and negotiate with others
• Ability to set standards and objectives and monitor progress
• Complex problem solving and decision-making skills
• Customer relationships
• Development of people