Regulatory Affairs Portfolio Lead at Boardroom Appointments

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 MRA's 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 regulator's 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:

• Bachelor's 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