Regulatory Affairs Portfolio Lead

JorDan HR; Midrand; On-site; ZAR 600,000 - 800,000; Full time

Job summary

A pharmaceutical company is seeking a Regulatory Affairs Portfolio Lead to manage product outputs and ensure compliance with South African regulations. The ideal candidate will hold a relevant pharmacy degree and have at least 3 years of experience in regulatory affairs, ideally in human medicines. The role requires strategic thinking and strong problem-solving skills, alongside excellent written communication abilities.

Qualifications

• Bachelor's degree in pharmacy or Diploma in Pharmacy required.
• 3 years experience in Regulatory Affairs preferably in human medicines.
• Experience in quality-driven processes and additional experience in African territories preferred.

Responsibilities

• Manage a portfolio of product outputs ensuring compliance with regulatory authorities.
• Support the Regulatory Affairs team with superior regulatory services.
• Control and manage regulatory applications to ensure timely processing.

Skills

Proofreading

Writing Skills

Strategic thinking

Complex problem solving

Education

Bachelors degree in pharmacy

Diploma in Pharmacy

Tools

CTD software

Adobe Acrobat

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

• Bachelors 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 CAPAs Root cause investigations
• Additional experience in African territories is preferable.

Core competencies

• Experience in use of CTD software builder and compilation of eCTD applications.
• 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 decisionmaking skills
• Customer relationships
• Development of people

Key Skills

Proofreading,Adobe Acrobat,FDA Regulations,Manufacturing & Controls,Biotechnology,Clinical Trials,Research & Development,GLP,cGMP,Product Development,Chemistry,Writing Skills

Employment Type : Full-Time

Experience : years

Vacancy : 1

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