Health Manager 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 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.

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Please take note that the applicants who do not adhere to the above criteria will not be considered for the respective position.

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If you have not received a response within two (2) weeks from applying, your application was most likely unsuccessful.