Regulatory Affairs Portfolio Lead

Job Purpose:

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.

Key Job Outputs:

• Manage work streams for and report on the assigned portfolio of products:

  - Assisting with internal product queries from relevant departments

  - Assisting with external product queries from the SAHPRA other MRAs and third-party stakeholders

  - Establish regulatory priorities and allocate resources and workloads

  - Review regulatory agency submission of materials to ensure timelines accuracy comprehensiveness or compliance with regulatory standards

  - Artwork reviews and approvals

• Co-ordination and submission of new product applications in South Africa and other applicable territories including but not limited to

  - Develop regulatory strategies and implementation plans for the preparation and submission of new products

  - Conduct dossier due diligence to ensure all data gaps are addressed

  - Prepare the registration applications for submission to the regulatory authorities

  - Work in collaboration with internal and external stakeholders to assess the regulators submission requirements

• Ensure the maintenance and/or update of existing registrations in accordance with the relevant legislation regulations and guidelines
• Maintain current knowledge of relevant Acts Regulations and Guidelines pertaining to the pharmaceutical industry.
• Internal training and mentoring

• Establish and maintain effective relationships with Regulatory Authorities internal and external stakeholders
• Formulate or implement regulatory affairs systems policies and procedures to ensure that regulatory compliance is maintained or enhanced including reporting and metrics management.
• Support activities such as internal audits or regulatory agency inspections
• Ensure alignment of personal and company values.

Qualifications/Experience:

• Bachelors degree in pharmacy/Diploma in Pharmacy and Registration with the South African Pharmacy Council
• 3 years experience in Regulatory Affairs preferably in human medicines with experience across product development commercialisation and maintenance lifecycle
• Demonstrable experience in quality-driven processes such as risk management change control deviations CAPAs Root cause investigations
• Additional experience in African territories is preferable
• Sound project management capabilities with an understanding of the medicines value chain
• Proven ability to consistently deliver to quality time and cost standards

Core competencies:

• Experience in the 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
• 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

Should you not be contacted within 2 weeks please take your application as unsuccessful.