Medical Drug Development and Regulatory Processes Manager
4 weeks ago
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.
- Please Apply Online and complete your registration on Ditto Hire (our application tracking system) to enable and protect you as a candidate to accept the new POPIA terms and conditions. This will then create your permanent profile with which you can apply for all jobs as advertised by AJ PERSONNEL. However, you may remove your profile from AJ PERSONNEL when you are no longer in the job market.
- AJ Personnel is fully POPIA Compliant.
- Please take note that the applicants who do not adhere to the above criteria will not be considered for the respective position.
- Note our clients may expire jobs at their own discretion.
- AJ PERSONNEL will only respond to shortlisted candidates.
- If you have not received a response within two (2) weeks from applying, your application was most likely unsuccessful.
-
Parktown, South Africa AJ Personnel Full time**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...
-
Parktown, South Africa AJ Personnel Full timeMain 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...
-
Medical Project Manager
3 weeks ago
Parktown, South Africa AJ Personnel Full timeMain purpose of the job: Project manage and support the drug development and regulatory processes workstream of the market shaping output Location: Parktown – Johannesburg 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...
-
Project Manager
5 days ago
Parktown, South Africa AJ Personnel Full time**Main purpose of the job**: - Project manage and support the drug development and regulatory processes workstream of the market shaping output **Location**: - **Parktown - Johannesburg** **Key performance areas**: - Project manage and support the drug development and regulatory processes workstream. - Together with the senior technical specialist, work...
-
Medical Project Manager
7 days ago
Parktown, South Africa AJ Personnel Full time**Main purpose of the job**: - Project manage and support the drug development and regulatory processes workstream of the market shaping output **Location**: - **Parktown - Johannesburg** **Key performance areas**: - Project manage and support the drug development and regulatory processes workstream - Together with the senior technical specialist, work...
-
Technical Lead
4 weeks ago
Parktown, South Africa AJ Personnel Full time**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...
-
Medical Market Access Manager
4 weeks ago
Parktown, South Africa AJ Personnel Full time**Main purpose of the job**: - Assume overall direct responsibility for the deliverable of the Market Shaping output, manage all milestones, timelines, and any emerging interdependencies - Lead the implementation of the Market Shaping working **Location**: - **Parktown - Johannesburg** **Key performance areas**: - Provide overall project leadership of...
-
Medical Market Shaping Manager
3 weeks ago
Parktown, South Africa AJ Personnel Full timeMain purpose of the job: Assume overall direct responsibility for the deliverable of the Market Shaping output, manage all milestones, timelines, and any emerging interdependencies Lead the implementation of the Market Shaping working Location: Parktown – Johannesburg Key performance areas: Provide overall project leadership of market surveillance...
-
Medical Marketing Specialist Market Shaping
3 weeks ago
Parktown, South Africa AJ Personnel Full timeMain purpose of the job: Assume overall direct responsibility for the deliverable of the Market Shaping output, manage all milestones, timelines, and any emerging interdependencies Lead the implementation of the Market Shaping working Location: Parktown – Johannesburg Key performance areas: Provide overall project leadership of market surveillance...
-
Project Manager
4 weeks ago
Parktown, South Africa AJ Personnel Full time**Main purpose of the job**: - Project manage and support the supplier engagement and contract management workstream of the market shaping output **Location**: - **Parktown - Johannesburg** **Key performance areas**: - Project manage and support the supplier engagement and contract management workstream - Together with the senior technical specialist,...
-
Health Market Shaping Manager
2 weeks ago
Parktown, South Africa Adzuna ZA B C2 Full timeMain purpose of the job:Assume overall direct responsibility for the deliverable of the Market Shaping output, manage all milestones, timelines, and any emerging interdependenciesLead the implementation of the Market Shaping workingLocation:Parktown – JohannesburgKey performance areas:Provide overall project leadership of market surveillanceDevelop market...
-
Regulatory Affairs Pharmacist
3 weeks ago
Parktown, South Africa The Perfect Placements Full timeOur client, a leading company in the pharmaceuticals industry is looking for qualified, career-driven, motivated, passionate, results-driven, team player, analytical and resilient Regulatory Affairs Pharmacist. - **This position will be based at their head office in Parktown, Gauteng**_ **Key Performance Areas**: - Compilation and submission of Post...
-
Regulatory Affairs Pharmacist
4 weeks ago
Parktown, South Africa The Perfect Placements Full timeOur client, a leading company in the pharmaceuticals industry is looking for qualified, career-driven, motivated, passionate, results-driven, team player, analytical and resilient Regulatory Affairs Pharmacist. - **This position will be based at their head office in Parktown, Gauteng**_ **Key Performance Areas**: - Compilation and submission of Post...
-
Technical Lead
4 weeks ago
Parktown, South Africa AJ Personnel Full time**Main purpose of the job**: - Lead the supplier engagement and contract management workstream for the market-shaping output **Location**: - **Parktown - Johannesburg** **Key performance areas**: - Lead the supplier engagement and contract management workstream - Work closely with CHAI, and oversee the supplier management/deal negotiation process - Work...
-
Medical Receptionist
4 weeks ago
Parktown, South Africa iMedrecruit Full time_**MEDICAL RECEPTIONIST, PARKTOWN, JOHANNESBURG**_ Our client, a Plastic and Reconstructive Surgeon based in Parktown, Johannesburg, is seeking to recruit a well presented and experienced medical receptionist. **Requirements**: - Greet and assist patients in a courteous and kind manner, whether in person or telephonically. - Schedule appointments and...
-
Anti-money Laundering Regulatory Specialist
4 weeks ago
Parktown, South Africa Hollard Recruitment Full time**Job Advert Summary**: **Key Responsibilities** **STR/ CTR/ Section 27 & Other Reports** - Attend to FICA ad-hoc issues,i.e., KYC queries, reporting of cash transactions above threshold, suspicious transactions, section 27 requests and any other reports. - Keep abreast of all AML/CTF/PF/FAT developments and ensure same is communicated to business where...
-
Medical Receptionist, Oncology
7 days ago
Parktown, South Africa Kontak Recruitment SA Full timeParktown, Johannebsurg - Healthcare **Medical Receptionist (JB3111)** Parktown, Johannesburg R11 000 - R15 000 per month Duration: Contract, for duration of Articles **Requirements**: Previous experience as a Medical Receptionist or in a similar role is preferred. Ability to multitask and prioritize tasks in a fast-paced environment. Proficiency in using...
-
Junior Bookkeeper
4 weeks ago
Parktown, South Africa iMedrecruit Full time**Junior Bookkeeper (Medical Practice Experience) Parktown West, Gauteng** Our client, a Specialist Oncologist, is seeking to recruit a junior bookkeeper with medical billing and collections knowledge to manage the financial aspects of the practice and who has the ability to prepare financial documentation required by the...
-
Clinical Trials Manager
4 weeks ago
Parktown, South Africa AJ Personnel Full time**Main purpose of the job**: - Ensure compliant, timely, and cost-efficient delivery of clinical projects across a portfolio through technical input and ongoing review and evaluation of project performance, in collaboration with project teams **Location**: - **Ezintsha - 32 Princess of Wales Terrace, Parktown - Johannesburg** **Key performance...
-
Learning and Development Manager
7 days ago
Parktown, South Africa Rand Mutual Assurance Full time**THE JOB AT A GLANCE** The Learning and Development Manager will be responsible for managing the Learning & Development function and ensuring all L&D initiatives are aligned with the HC strategy as well as the overall business strategy for the achievement of RMA’s operational and strategic objectives and its commitment to a building a high-performance...