This position plays a pivotal role in developing regulatory strategy, maintaining compliance, and facilitating successful market expansion for both human pharmaceuticals and animal health products.
The ideal candidate will spearhead a range of responsibilities, including driving strategic initiatives, overseeing key projects, and ensuring alignment with organizational objectives. They will collaborate closely with senior leadership to implement innovative solutions, optimize processes, and foster a high-performance culture. The role demands strong analytical skills, exceptional leadership capabilities, and the ability to manage cross-functional teams effectively. A proven track record in similar positions, along with expertise in [relevant industry/field], is essential. Additionally, the candidate must demonstrate outstanding communication skills, adaptability to evolving business needs, and a commitment to achieving measurable results.
Developing and implementing regulatory strategies ensures adherence to applicable laws and guidelines while driving organizational objectives.
Proactively handles the compilation and management of ACTD/CTD dossiers, ensuring thorough preparation and timely submission in compliance with regulatory standards.
The professional is responsible for overseeing product registrations, managing renewal processes, and handling lifecycle management activities.
Engaging with regulatory authorities across various African nations ensures compliance and fosters strategic partnerships to navigate complex regional frameworks effectively.
Liaising with Chief Medical Officers, Contract Research Organizations, Quality Assurance, Research & Development, and Supply Chain teams is essential to ensure seamless collaboration and alignment of objectives.
Professionally, the position involves deploying and managing Risk and Information Management Systems (RIMS) as well as digital regulatory compliance platforms. This role requires expertise in integrating these systems with existing infrastructure while ensuring adherence to regulatory standards. Additionally, the candidate will be responsible for optimizing system performance, troubleshooting technical issues, and providing training and support to end-users. Strong analytical and project management skills are essential, along with proficiency in relevant software and compliance frameworks.
Provides leadership to the team, develops capabilities, and manages performance to drive results and ensure high standards of execution.
Key Requirements
To qualify for this position, applicants must meet the following criteria:
A bachelor’s degree in Pharmacy, Veterinary Medicine, Pharmaceutical Sciences, or a related scientific discipline is required for this position.
With a minimum of seven years of dedicated experience in regulatory affairs within the pharmaceutical sector, you should also possess familiarity with African markets.
Professionals seeking this role must possess extensive hands-on expertise in preparing, submitting, and reviewing ACTD/CTD dossiers to ensure compliance with regulatory standards and facilitate successful approval processes.
Experienced professionals with a strong background in managing product registrations, handling renewals and variations, and overseeing lifecycle processes are sought after for this role. Candidates should demonstrate expertise in ensuring compliance and efficiency throughout each stage of a product’s lifecycle, from initial registration through to ongoing management and updates.
Professional experience with locally produced goods and contract manufacturing organizations (CMOs) is highly desirable.
Experienced in managing bioequivalence studies in collaboration with contract research organizations (CRO’s), with a preference for prior involvement in such partnerships.
Profound knowledge of pharmaceutical regulatory frameworks spanning various African nations is essential.
Proficiency in regulatory systems, monitoring tools, or Risk Information Management Systems (RIMS) platforms would be considered a valuable asset.
The ideal candidate must demonstrate exceptional leadership abilities, expertise in managing stakeholders effectively, and a proven capacity for collaborating seamlessly across diverse teams.
We invite you to forward your curriculum vitae to our dedicated email address, jobs@talentgridafrica.com, for consideration.
Qualifications
BA/BSc/HND
Experience Required
7 years
