This position plays a pivotal role in developing regulatory strategies, maintaining compliance, and facilitating the successful expansion of markets for human pharmaceutical and animal health products.
The ideal candidate will be responsible for spearheading key initiatives, ensuring strategic alignment with organizational objectives. They will manage and guide cross-functional teams, fostering collaboration and driving performance to achieve measurable results. Additionally, the candidate will oversee project execution, monitor progress, and implement best practices to maintain operational excellence. Strong leadership, problem-solving skills, and a results-driven mindset are essential for this role.
We are seeking a professional capable of formulating and implementing regulatory strategies with precision and efficiency. The role involves crafting strategic approaches to navigate complex regulatory landscapes while ensuring compliance with applicable laws and guidelines. Key responsibilities include developing actionable plans to address regulatory challenges, aligning business objectives with regulatory requirements, and overseeing the execution of these initiatives to achieve organizational goals. The ideal candidate will possess a strong understanding of regulatory frameworks and demonstrate the ability to translate intricate requirements into practical, actionable steps.
Responsible for compiling and submitting ACTD/CTD dossiers, ensuring compliance with regulatory standards and timelines.
We are responsible for managing product registrations, handling renewals, and overseeing the entire product lifecycle to ensure seamless operations and compliance with regulatory standards.
Regulatory engagement spanning various African jurisdictions requires active participation in interactions with local regulatory bodies and authorities.
Collaboration with Chief Medical Officers, Contract Research Organizations, Quality Assurance, Research & Development, and Supply Chain teams is required.
The establishment and integration of Regulatory Information Management Systems (RIMS) along with advanced digital regulatory platforms are essential responsibilities. This role involves deploying and maintaining these systems to ensure compliance with evolving regulatory standards. Proficiency in RIMS configuration, system optimization, and troubleshooting is required, along with a strong understanding of digital regulatory frameworks. Candidates must possess expertise in system implementation and the ability to align regulatory processes with technological advancements.
Strong leadership, talent development, and performance oversight drive operational excellence in this role.
Experienced candidates should possess a robust background in [specific field/discipline], supported by a relevant bachelor’s or advanced degree. Proficiency in [specific skills or tools] is essential, along with a minimum of [X] years of hands-on experience in [specific area]. Strong analytical abilities and meticulous attention to detail are required to ensure accuracy and efficiency. Exceptional communication skills, both written and verbal, are necessary for collaborating with cross-functional teams and stakeholders. Familiarity with [industry-specific regulations, standards, or systems] is strongly preferred. The ability to work independently, manage deadlines, and adapt to evolving priorities is critical. Candidates must demonstrate a commitment to continuous learning and professional growth.
Candidates meeting the eligibility criteria for this position must possess the following qualifications:
A degree in Pharmacy, Veterinary Medicine, Pharmaceutical Sciences, or a comparable scientific discipline at the bachelor’s level is required.
With a minimum of seven years of regulatory affairs experience in the pharmaceutical sector, candidates must also demonstrate familiarity with African markets.
Experienced in preparing, submitting, and reviewing ACTD/CTD dossiers with a high degree of proficiency is essential.
With a strong track record in managing product registrations, renewals, variations, and lifecycle oversight, you bring substantial expertise to this role.
Professionals who possess hands-on experience collaborating with domestic manufacturers and contract manufacturing organizations—ideally with a preference for CMOs—will be given strong consideration.
Experience coordinating bioequivalence studies with CROs (preferred)
Proficient in navigating pharmaceutical regulatory frameworks spanning multiple African nations.
Proficiency in regulatory systems, tracking tools, or RIMS platforms is considered beneficial.
Proven expertise in leading teams, engaging stakeholders, and fostering seamless collaboration across diverse functions is essential.
Please submit your CV to jobs@talentgridafrica.com for consideration.
Qualifications
BA/BSc/HND
Experience Required
7 years
