Health Manager Drug Development and Regulatory Processes

Main purpose of the job:Lead the drug development and regulatory processes workstream for the market-shaping outputLocation:Parktown - JohannesburgKey performance areas:Lead the drug development & regulatory processes workstreamWork closely with CHAI and lead product development, regulatory, and quality assurance processesWork closely with the CHAI's US-based product development and regulatory team and develop plans to accelerate generic product developmentWork 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 strategiesEngage in job shadowing (of CHAI) during technical meetings with generic manufacturers and strategy developmentDevelop and maintain a strong working relationship with CHAI, manufacturers, and other stakeholders as relates to the drug development & regulatory processes workstreamConvene and/or attend and lead drug development and regulatory stakeholder meetingsWork closely with CHAI to establish appropriate relationships with key stakeholders within the drug development & regulatory environmentOversee the planning and coordination of the drug development & regulatory workstreamEnsure coordination with the supplier engagement and contract management workstreamActively participate in key global, regional, and national stakeholder foraLine 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 necessaryReport monthly on key achievements, challenges, and any anecdotal success storiesContribute to and support financial management and control as related to the above human resources and other activitiesPlan, convene, and produce reports for monthly one-on-one meetings with supervised staff to monitor performance and supportAttend to all staffing requirements and administrationOversee the duties of subordinates to ensure optimal staff utilization and maintenance of sound labor relationsPlan, organize and lead staff performance assessmentsIdentify substandard performance by team members and plan and implement necessary corrective actionCoach and train subordinates and team members to ensure the acquisition of knowledge and skills required by the organizationLead the promotion of harmony, teamwork, and sharing of informationProvide day-to-day support to all project staffTake ownership and accountability for tasks and demonstrate effective self-managementFollow through to ensure that quality and productivity standards of own work are consistently and accurately maintainedMaintain a positive attitude and respond openly to feedbackTake 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 affairsRequired minimum work experience:Minimum 8 years of private sector work experience, with a focus on product development and commercialization and regulatory affairsSuccessful 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 efficacyHelping to establish succinct regulatory filing strategies to support the filing of regulatory dossiers that demonstrate a new product's safety, efficacy, and qualitySupporting the development and commercialization of drug products, drug-device combinations, and medical devicesPerforming Current Good Manufacturing Practice (cGMP) gap analyses and reviewing regulatory submissions for new innovator and generic product manufacturersExperience developing strategies to overcome key barriers and issues related to product development, filing, approval, introduction, and adoptionExtensive 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 manufacturersExperience supporting the capacitation of new/junior team members with more limited experience in product development and commercialization and regulatory affairsAbility to collaborate remotely with team members spread across geographiesDesirable 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-appropriateDemands of the job:Travel will be required within and outside of South AfricaWork can be highly demanding and pressurized, and requires flexibility, management, training, and leadership experienceTO 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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