Medical Drug Development and Regulatory Processes

**Main purpose of the job**:

- Lead the drug development and regulatory processes workstream for the market-shaping output

**Location**:

- **Parktown - Johannesburg**

**Key performance areas**:

- Lead the drug development & regulatory processes workstream
- Work closely with CHAI and lead product development, regulatory, and quality assurance processes
- Work closely with the CHAI’s US-based product development and regulatory team and develop plans to accelerate generic product development
- Work closely with CHAI’s US-based product development and regulatory team to assess and mitigate product development risks with generic partners and support innovative regulatory strategies
- Engage in job shadowing (of CHAI) during technical meetings with generic manufacturers and strategy development
- Develop and maintain a strong working relationship with CHAI, manufacturers, and other stakeholders as relates to the drug development & regulatory processes workstream
- Convene and/or attend and lead drug development and regulatory stakeholder meetings
- Work closely with CHAI to establish appropriate relationships with key stakeholders within the drug development & regulatory environment
- Oversee the planning and coordination of the drug development & regulatory workstream
- Ensure coordination with the supplier engagement and contract management workstream
- Actively participate in key global, regional, and national stakeholder fora
- Line manage and give day-to-day direction to one project manager: drug development and regulatory processes. Dotted line management of two other positions (project administrator and project statistician)
- Attend manufacturer site visits as necessary
- Report monthly on key achievements, challenges, and any anecdotal success stories
- Contribute to and support financial management and control as related to the above human resources and other activities
- Plan, convene, and produce reports for monthly one-on-one meetings with supervised staff to monitor performance and support
- Attend to all staffing requirements and administration
- Oversee the duties of subordinates to ensure optimal staff utilization and maintenance of sound labor relations
- Plan, organize and lead staff performance assessments
- Identify substandard performance by team members and plan and implement necessary corrective action
- Coach and train subordinates and team members to ensure the acquisition of knowledge and skills required by the organization
- Lead the promotion of harmony, teamwork, and sharing of information
- Provide day-to-day support to all project staff
- Take ownership and accountability for tasks and demonstrate effective self-management
- Follow through to ensure that quality and productivity standards of own work are consistently and accurately maintained
- Maintain a positive attitude and respond openly to feedback
- Take ownership of driving your career development by participating in ongoing training and development activities such as forums, conferences, policy-setting workshops, etc.

**Required minimum education and training**:

- **A Graduate-level Technical Degree with significant experience in product development commercialization and regulatory affairs**

**Required minimum work experience**:

- **Minimum 8 years of private sector work experience, with a focus on product development and commercialization and regulatory affairs**:

- **Successful experience accelerating preclinical and clinical research and product development by implementing efficient and effective drug development and regulatory strategies for these products. This should include specific experience**:

- **Guiding companies/partners to perform various types of bioequivalence (BE) studies, pharmacokinetics/pharmacodynamics (PK/PD) studies, and randomized controlled clinical trials (RCT) to assess safety and efficacy**:

- **Helping to establish succinct regulatory filing strategies to support the filing of regulatory dossiers that demonstrate a new product’s safety, efficacy, and quality**:

- **Supporting the development and commercialization of drug products, drug-device combinations, and medical devices**:

- **Performing Current Good Manufacturing Practice (cGMP) gap analyses and reviewing regulatory submissions for new innovator and generic product manufacturers**
- **Experience developing strategies to overcome key barriers and issues related to product development, filing, approval, introduction, and adoption**:

- **Extensive experience managing relationships with manufacturers, procurement and other partners, Stringent Regulatory Authority (SRAs), National Drug Regulatory Authorities (NDRAs), Ministries of Health, and other key stakeholders, including both innovator and generic product manufacturers**:

- **Experience supporting the capacitation of new/junior team members with more limited experience in product development and commercialization and regulatory affairs**:

- **Ability to collaborate