This position plays a pivotal role in developing regulatory strategies, maintaining compliance, and facilitating successful market expansion for human pharmaceutical and animal health products.
The ideal applicant will spearhead initiatives that drive organizational growth and innovation, overseeing key projects and ensuring strategic alignment with company objectives. They will be responsible for managing cross-functional teams, optimizing processes, and fostering a culture of collaboration and accountability. Additionally, the candidate must demonstrate strong leadership, exceptional problem-solving skills, and the ability to inspire and mentor high-performing teams.
Responsible for formulating and implementing robust regulatory strategies to ensure compliance with applicable laws and guidelines.
We are responsible for compiling and submitting ACTD/CTD dossiers, ensuring all regulatory requirements are met with precision and efficiency. This role involves meticulous preparation of documentation, adherence to submission timelines, and collaboration with cross-functional teams to maintain compliance. Proficiency in dossier management and a keen attention to detail are essential for success in this position.
Product registrations, renewals, and lifecycle oversight are managed to ensure seamless processing and maintenance.
Regulatory engagement initiatives span numerous African nations, requiring coordination with diverse governmental and regulatory bodies to ensure compliance with local laws and industry standards.
The position involves collaborating closely with Chief Medical Officers (CMOs), Contract Research Organizations (CRO’s), Quality Assurance (QA), Research & Development (R&D), and Supply Chain teams.
The establishment and deployment of Regulatory Information Management Systems (RIMS) and digital regulatory platforms are required, encompassing the full lifecycle from system integration to ongoing maintenance and support. Key responsibilities include configuring these systems to align with organizational policies, ensuring compliance with regulatory standards, and facilitating seamless data management across departments. Proficiency in system implementation methodologies, regulatory frameworks, and digital transformation strategies is essential, along with the ability to collaborate with cross-functional teams to optimize system performance and user adoption.
The position requires strong leadership skills to guide and inspire teams, fostering a culture of growth and excellence. Responsibilities include nurturing talent through capability development initiatives and ensuring consistent performance standards are met.
Key qualifications include a Bachelor’s degree in a relevant field, at least three years of hands-on experience in the industry, and strong proficiency in industry-standard software tools. Candidates must demonstrate exceptional problem-solving skills, attention to detail, and the ability to collaborate effectively in a team setting. Additionally, familiarity with current trends and best practices, as well as the capacity to manage multiple priorities in a fast-paced environment, are essential. Prior leadership or mentorship experience is highly desirable, along with excellent written and verbal communication abilities.
To qualify for this position, applicants must possess the following:
A Bachelor’s degree in Pharmacy, Veterinary Medicine, Pharmaceutical Sciences, or an allied scientific discipline is essential.
With a minimum of seven years of experience in regulatory affairs within the pharmaceutical sector, candidates should demonstrate familiarity with African market dynamics.
Experienced in compiling, submitting, and evaluating ACTD/CTD dossiers with a proven track record.
Demonstrated expertise in managing product registrations, renewals, variations, and comprehensive lifecycle oversight is required.
Proficiency in collaborating with locally produced goods and contract manufacturing organizations (CMOs) is strongly preferred.
Seasoned professionals with a proven track record in managing collaborative bioequivalence studies alongside Contract Research Organizations (CRO’s) are strongly encouraged to apply.
Possesses comprehensive knowledge of pharmaceutical regulatory requirements spanning diverse African jurisdictions, with expertise in navigating varying compliance standards and frameworks across the continent.
Proficiency in regulatory systems, tracking tools, or RIMS platforms is considered beneficial.
Accomplished leadership capabilities, adept stakeholder engagement, and seamless cross-functional teamwork form the core competencies required for this role, ensuring effective influence and alignment across diverse teams and business units.
Please submit your CV to jobs@talentgridafrica.com for consideration.
Qualifications
BA/BSc/HND
Experience Required
7 years
