About the position
Main purpose of the job:
- Project manage and support the drug development and regulatory processes workstream of the market shaping output
Location:
Key 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 affairs
Required minimum work experience:
- Minimum 6 years of private sector work experience, with a focus on product development and commercialization and regulatory affairs
- Experience supporting successful acceleration of 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 supporting efforts to:
- Guide 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.
- Help to establish succinct regulatory filing strategies to support the filing of regulatory dossiers that demonstrate a new product’s safety, efficacy, and quality.
- Support the development and commercialization of drug products, drug device combinations, and medical devices.
- Perform Current Good Manufacturing Practice (cGMP) gap analyses and reviewing regulatory submissions for new innovator and generic product manufacturers
- Experience supporting development of strategies to overcome key barriers and issues related to product development, filing, approval, introduction and adoption.
- Experience Translating above-mentioned strategies into actionable items
- Ability to collaborate remotely with team members spread across geographies
Desirable additional education, work experience and personal abilities
Good interpersonal skills and ability to navigate complicated situations, excellent levels of written and verbal English communication skills, ability to communicate in other SA languages, preferably area appropriate.
Demands of the job
Travel will be required within and outside of South Africa. Work can be highly demanding and pressurized, and requires flexibility, management, training, and leadership experience.
TO APPLY:
- Only if you do meet the minimum job requirements and experience as mentioned above, you may submit a detailed updated CV.
- Please Apply Online.
- Please take note that the applicants who do not adhere to the above criteria will not be considered for the respective position.
- The closing date for all applications: 02 April 2024.
- Note AJ Personnel is fully POPI compliant.
- Note WHC, in accordance with their Employment Equity goals and plan, will give preference to suitable applicants from designated groups as defined in the Employment Equity Act 55 of 1998 and subsequent amendments thereto.
Please note:
- AJ PERSONNEL is only responsible for the advertising of the advertisement on behalf of their client Wits Health Consortium.
- Wits Health Consortium will only respond to shortlisted candidates.
- Candidates who have not been contacted within two weeks of the closing date can consider their applications to be unsuccessful.
- AJ Personnel does not have any salary or other information regarding the position.
Desired Skills:
- Communication
- Computer Skills
- Healthcare
- Medical
- Pharmaceutical
- Public / Non-Profit Administration
- Regulatory Rules
About The Employer:
The Wits Reproductive Health and HIV Institute (Wits RHI) is a renowned African-led research institute that seeks solutions to Africa’s health [URL Removed] is located within the University of the Witwatersrand and addresses some of the greatest public health concerns affecting our region, including HIV and its related problems, sexual and reproductive health, and vaccinology.
Employer & Job Benefits:
- Medical Aid Contribution
- Provident Fund Contribution
