This position plays a pivotal role in developing regulatory strategy, maintaining compliance, and facilitating successful market expansion for both human pharmaceutical and animal health products.
The chosen individual will be responsible for spearheading initiatives and managing key projects to drive organizational success. This role requires overseeing strategic objectives, fostering team collaboration, and ensuring alignment with company goals. The ideal candidate will demonstrate strong leadership skills, possess relevant experience in the field, and exhibit the ability to motivate and mentor teams. Additionally, they will be tasked with analyzing performance metrics, identifying growth opportunities, and implementing innovative solutions to enhance productivity and efficiency. A commitment to continuous improvement and a results-driven mindset are essential for this position.
Responsibilities include formulating and implementing robust regulatory strategies to ensure compliance and drive successful outcomes. This role involves developing strategic approaches to navigate complex regulatory landscapes, ensuring alignment with evolving requirements while supporting business objectives. Key tasks encompass crafting comprehensive plans, assessing risks, and collaborating with cross-functional teams to execute initiatives effectively. The position demands a deep understanding of regulatory frameworks, strong analytical skills, and the ability to translate intricate requirements into actionable strategies.
Experienced professionals are responsible for compiling, reviewing, and finalizing ACTD/CTD dossiers in compliance with regulatory standards. This includes assembling comprehensive documentation, ensuring accuracy, and meeting submission deadlines across various global markets. Proficiency in regulatory guidelines, meticulous attention to detail, and strong organizational skills are essential for effectively managing dossier preparation and facilitating smooth regulatory submissions.
Handle the complete spectrum of product registration processes, including initial registration, renewal, and ongoing lifecycle management.
Engaging with regulatory bodies across various African countries is a key responsibility of this role, requiring interaction with diverse national authorities to ensure compliance and alignment with local guidelines.
Collaboration with Chief Medical Officers, Contract Research Organizations, Quality Assurance, Research & Development, and Supply Chain teams is essential.
The establishment and integration of RIMS and digital regulatory systems will be undertaken to ensure compliance and operational efficiency. This role involves deploying and maintaining these systems to support regulatory processes and data management. Proficiency in regulatory frameworks and digital tools is essential, along with the ability to troubleshoot and optimize system performance. Collaboration with cross-functional teams will be necessary to align system functionalities with organizational needs and evolving regulatory requirements.
Experienced professionals skilled in leading teams, developing capabilities, and driving performance are sought. The role requires expertise in guiding and motivating teams, fostering skill enhancement among members, and ensuring consistent performance outcomes. Strong leadership acumen, a commitment to talent development, and a results-driven approach are essential for success in this position.
As indispensable qualifications for consideration, candidates must demonstrate proficiency in strategic planning, possess exceptional communication skills, and exhibit a minimum of five years of relevant industry experience. Additionally, the role necessitates a proven ability to lead cross-functional teams, a strong track record in delivering measurable results, and a deep understanding of current market trends. Proficiency in data analysis and project management tools is also required, along with a commitment to fostering a collaborative and innovative work environment.
Candidates must meet the following criteria to be eligible for this position:
A bachelor’s degree in Pharmacy, Veterinary Medicine, Pharmaceutical Sciences, or a related scientific discipline is required.
With a minimum of seven years of dedicated regulatory affairs experience within the pharmaceutical sector, expertise in navigating African markets is essential.
Proven expertise in the preparation, submission, and review of ACTD/CTD dossiers is required.
Demonstrated expertise in managing product registrations, renewals, variations, and overseeing the entire lifecycle of product compliance is essential.
Candidates should possess experience collaborating with locally produced goods and contract manufacturing organizations (CMOs), with a preference for those with prior CMO involvement.
Seasoned in managing bioequivalence studies through collaborations with Contract Research Organizations (CRO’s) is highly desirable.
Possesses a comprehensive knowledge of pharmaceutical regulatory frameworks spanning various African countries.
Proficiency in regulatory systems, tracking tools, or RIMS platforms is considered a beneficial qualification.
Effective leadership abilities, adeptness in stakeholder engagement, and a proven capacity for cross-functional teamwork are required.
Should you wish to apply, kindly forward your curriculum vitae to jobs@talentgridafrica.com.
Qualifications
BA/BSc/HND
Experience Required
7 years
