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 candidate will be responsible for spearheading key initiatives by providing strategic direction and ensuring alignment with organizational objectives. This individual will oversee and manage critical projects, fostering collaboration across teams to drive innovation and operational excellence. Additionally, the role demands a proactive approach to problem-solving, with the ability to analyze complex challenges and implement effective solutions. Strong leadership, exceptional communication skills, and a results-driven mindset are essential to succeed in this position. Prior experience in a similar role and a proven track record of achieving measurable outcomes are required.
Developing and implementing strategic regulatory approaches is a key responsibility, ensuring alignment with applicable guidelines and requirements while driving efficient execution to achieve compliance objectives.
Responsible for compiling and submitting ACTD/CTD dossiers, ensuring compliance with regulatory standards while maintaining accuracy and completeness throughout the preparation process.
The professional handles product registrations, manages renewals, and oversees lifecycle management to ensure seamless operations.
Regulatory engagement activities span across numerous African nations, ensuring alignment with diverse jurisdictional frameworks and compliance standards. This role involves active interaction with local regulatory authorities to facilitate seamless operations and uphold stringent industry requirements.
Collaboration with Chief Medical Officers, Contract Research Organizations, Quality Assurance, Research and Development, and Supply Chain teams will be integral to this role.
We will deploy RIMS and other digital regulatory frameworks to ensure comprehensive compliance and operational efficiency. This initiative involves integrating advanced regulatory information management systems and cutting-edge digital solutions to streamline compliance processes. Responsibilities include overseeing system implementation, managing data integrity, facilitating regulatory reporting, and ensuring alignment with evolving regulatory standards. Candidates should possess expertise in regulatory compliance, strong analytical skills, and proficiency in digital system implementation.
We are seeking a leader who excels in guiding teams, developing capabilities, and driving performance outcomes. The ideal candidate will demonstrate strong leadership skills to inspire and direct teams effectively. Additionally, they will focus on capability building to enhance the skills and competencies of team members, ensuring continuous growth and improvement. Performance management will also be a key responsibility, with a focus on setting clear goals, providing constructive feedback, and fostering a high-performance culture.
As a valued applicant, you will demonstrate a strong foundation in relevant technical skills and expertise, with the ability to collaborate effectively within a team-oriented environment. Familiarity with industry-standard tools, methodologies, and best practices is essential, along with a commitment to continuous learning and professional development. The ideal candidate will possess excellent problem-solving abilities, strong communication skills, and the capacity to manage multiple priorities while maintaining high attention to detail. Prior experience in [specific field or role] and proficiency in [specific software, programming languages, or systems] are required, as is the capacity to work independently and contribute meaningfully to project goals. A proactive approach to troubleshooting and a dedication to delivering high-quality results are also expected.
Candidates must meet specific qualifications to be considered for this position, including:
A Bachelor’s degree in Pharmacy, Veterinary Medicine, Pharmaceutical Sciences, or a related scientific discipline is required for this position.
Minimum seven years of regulatory affairs experience within the pharmaceutical sector is required, with direct involvement in African market operations.
Proven expertise in compiling, submitting, and evaluating ACTD/CTD dossiers is required.
Experienced professionals must demonstrate a strong background in handling product registrations, managing renewals, implementing variations, and overseeing lifecycle processes.
Individuals with hands-on experience collaborating with domestically produced goods and contract manufacturing organizations are strongly encouraged to apply, with a preference for candidates familiar with CMOs.
With preference for candidates who have managed bioequivalence studies in collaboration with Contract Research Organizations (CRO’s).
• Comprehensive knowledge of pharmaceutical regulatory frameworks spanning diverse African nations
Proficiency in regulatory systems, tracking tools, or RIMS platforms is highly beneficial.
Accomplished leadership, adept stakeholder engagement, and seamless cross-functional teamwork define the ideal candidate, who must demonstrate exceptional proficiency in these areas.
Subject your application to jobs@talentgridafrica.com with your CV attached. Ensure your email is formatted professionally and clearly states the position you are applying for in the subject line.
Qualifications
BA/BSc/HND
Experience Required
7 years
