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Senior Technical Officer - Regulatory Systems Strengthening
March 16, 2022
An exciting global pharmaceutical client of ours is looking to hire a Senior Technical Officer - Regulatory Systems Strengthening(STO-RSS) must have expert skills in key pharmaceutical regulatory functions including Post-Marketing Surveillance (PMS), Quality Management Systems (QMS), Product Evaluation and Registration, Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP) and others. The STO-RSS will provide technical assistance to the National Medicines Regularity Authority “Agence du Medicament de Madagascar” (AMM) and to the Ministry of Health to build their capacity to regulate pharmaceutical products in Madagascar. The selected candidate will work with other PQM+ team members to assist AMM to implement relevant actions listed in the institutional development plan (IDP) of the agency, focusing on the PMS and other core regulatory functions, which will help improve WHO-GBT Maturity Level of AMM. He/she will provide technical oversight of the PMS and QMS related components of the PQM+’s objective of improving country and regional regulatory systems to assure the quality of medical products in the public and private sectors.
- Provide technical oversight of activities to support the regulatory functions of AMM
- Work with AMM to implement relevant actions listed in the institutional development plan (IDP) of the authority, focusing on PMS and other core regulatory functions, to assist the AMM improve the WHO-Global Benchmarking Tool (WHO-GBT) Maturity Level rating.
- Implement PQM+ technical activities under the guidance of the regional and US Rockville-based technical teams.
- Propose, design, and implement interventions aimed at strengthening the PMS, QMS and other core regulatory functions including the development and implementation of protocols, guidelines, procedures, and other relevant tools.
- Provide technical leadership and support to improve efficiency, effectiveness, and sustainability of PMS and other core regulatory processes.
- Work closely with AMM to support development and deployment of strategies towards improvement of national regulatory systems.
- Actively contribute to annual programmatic and resource planning process and development of quarterly and annual reports.
- Support development of country work plans and budgets.
- Collect and report program data and indicators; documents and translates program information; and helps in coordinating in-country program logistics for implementation of workplan activities.
- Lead and manages other PQM+ local staff and consultants in Madagascar.
- Performs other duties as assigned by the senior program manager.
- Travel in Africa 25% of the time.
- Bachelor’s degree in pharmaceutical sciences
- At least 8 years’ hands-on experience working in pharmaceutical regulation, quality management systems or pharmaceutical quality control
- Master’s degree in pharmaceutical sciences/pharmaceutical quality assurance and quality control of medicines is beneficial.
- Post-qualification training and implementation in pharmaceutical quality management systems is beneficial.
- Strong technical writing and communication skills and fluent in spoken and written English language.
- Ability to build relationships and interact effectively with technical experts, other partners, and donor agencies.
- Experience working with USAID projects preferred.
- Must possess ability to work independently and handle multiple priorities in a fast-paced environment
- Skills in training and workshop facilitation desired
- Demonstratable highest degree of ethics and integrity.
- Excellent interpersonal, leadership and organizational skills with strong attention to detail.
- Results driven with demonstrated successful outcomes
- Experience in managing and leading technical teams
If you wish to apply for the position, please send your CV to Jamie Adams at email@example.com
Please visit www.caglobalint.com for more exciting opportunities.
CA Global will respond to short-listed candidates only. If you have not had any response in two weeks, please consider your application unsuccessful however your CV will be kept on our database for any other suitable positions.