This position plays a pivotal role in developing regulatory strategy, upholding compliance, and facilitating successful market expansion for human pharmaceuticals and animal health products.
The ideal candidate will spearhead initiatives to drive strategic objectives, fostering collaboration across teams to achieve measurable outcomes. They will oversee key responsibilities, including but not limited to, project management, team leadership, and the implementation of innovative solutions tailored to organizational needs. Additionally, the role demands a proven track record in [specific industry or field], strong analytical capabilities, and the ability to mentor and develop high-performing teams while upholding operational excellence.
Develop and implement comprehensive regulatory strategies to ensure compliance and alignment with applicable laws and guidelines. This includes overseeing the formulation, documentation, and execution of strategic plans to address regulatory requirements, mitigate risks, and support organizational objectives. The role involves close collaboration with cross-functional teams to integrate regulatory considerations into business processes and decision-making frameworks.
Professional Rewriting:
Preparation and submission of ACTD/CTD dossiers form a key part of the responsibilities. This encompasses compiling, reviewing, and organizing all necessary documentation to ensure compliance with regulatory standards. Additionally, the role involves coordinating with cross-functional teams to gather required data, addressing queries from regulatory authorities, and maintaining accurate records throughout the dossier lifecycle. Proficiency in dossier management systems and adherence to timelines are essential to support timely submissions and maintain compliance.
The product registrations, renewals, and lifecycle management are handled by our team. This includes overseeing the entire process from initial registration to renewal and ensuring ongoing lifecycle management. Our responsibilities encompass maintaining accurate records, coordinating with stakeholders, and guaranteeing compliance with relevant regulations throughout each stage.
Engaging with regulatory bodies across diverse African nations constitutes a core aspect of this role, requiring seamless interaction with various governmental and industry-specific agencies.
Collaborate effectively with Chief Medical Officers, Contract Research Organizations, Quality Assurance, Research and Development, and Supply Chain teams to ensure seamless project execution.
The deployment and integration of Regulatory Information Management Systems (RIMS) and advanced digital regulatory platforms will be undertaken, ensuring full compliance with applicable regulatory frameworks and operational requirements.
Experienced professionals adept at leading teams, fostering skill development, and driving performance excellence are sought after. The ideal candidate will demonstrate proficiency in guiding groups toward shared objectives, enhancing individual capabilities through targeted development initiatives, and maintaining rigorous performance oversight to ensure sustained high standards.
Key Requirements
To qualify for this position, applicants must possess:
A bachelor’s degree in Pharmacy, Veterinary Medicine, Pharmaceutical Sciences, or a related scientific discipline is required.
With a minimum of seven years of regulatory affairs experience in the pharmaceutical industry, candidates must demonstrate familiarity with African markets.
Proven expertise in preparing, submitting, and reviewing ACTD/CTD dossiers is required.
Demonstrated expertise in managing product registrations, ensuring timely renewals, handling variations, and overseeing the full lifecycle of product submissions is essential.
Professional experience with locally manufactured products and contract manufacturing organizations (CMOs) is strongly preferred.
With a preference for prior experience in managing bioequivalence studies in collaboration with contract research organizations (CRO’s), candidates should demonstrate a proven track record in this domain.
Profound knowledge of pharmaceutical regulatory landscapes spanning various African nations is essential.
Proficiency in regulatory systems, monitoring tools, or RIMS platforms represents a valuable asset.
Accomplished leadership abilities, adept stakeholder engagement, and a proven capacity for seamless cross-functional teamwork are essential.
Please submit your CV to jobs@talentgridafrica.com for consideration.
Qualifications
BA/BSc/HND
Experience Required
7 years
