Project Manager (Drug Development and Regulatory P - Johannesburg
Main purpose of the job:Project manage and support the drug development and regulatory processes workstream of the market shaping outputLocation:Parktown – JohannesburgKey performance areas:Project manage and support the drug development and regulatory processes workstream.Together with the senior technical specialist, work closely with CHAI and lead product development, regulatory, and quality assurance processes.Together with the senior technical specialist, work closely with the CHAI’s US-based product development and regulatory team and develop plans to accelerate generic product development.Together with the senior technical specialist, work closely with CHAI’s US-based product development and regulatory team and assess and mitigate product development risks with generic partners and supporting 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.Assist and support the technical specialist to 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.Support the technical specialist with overseeing the planning and coordination of the drug development & regulatory workstream.Ensure coordination with the supplier engagement and contract management workstream.Contribute to the technical coordination between Wits RHI, Unitaid, CHAI and all other stakeholders and ensure that Wits RHI is represented.Support optimal communication between and across the Wits RHI and CHAI teams is optimal and that program activities are coordinated and leveraged.Contribute to the achievement of Wits RHI’s corporate goals and objectives. Actively participate in key global, regional, and national stakeholder.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.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 for driving own career development by participating in on-going 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 affairsRequired minimum work experience:Minimum 6 years of private sector work experience, with a focus on product de https://protool.gumtree.co.za/external-link-browser.html?urlaHR0cHM6Ly9lbi16YS53aGF0am9icy5jb20vY29vcG9iX19jcGxfX18xMTA4XzE4NTEzOF9fNDk3P3V0bV9zb3VyY2U9Z3VtdHJlZSZ1dG1fbWVkaXVtPWZlZWQma2V5d29yZD0&jid1794918&xid1108_185138
Apply Now
Facebook
WhatsappRelated Jobs
Medical Drug Development and Regulatory Processes Manager - Johannesburg
...
Regulatory Affairs Pharmacist Johannesburg - South Africa
Vela Personnel
...
Senior Regulatory Affairs Pharmacist Market related - South Africa
Vela Personnel
...