This position plays a pivotal role in developing regulatory strategy, maintaining compliance, and facilitating successful market expansion for human pharmaceutical and animal health products.
The ideal applicant will spearhead the following initiatives:
Develop and implement strategic regulatory approaches with precision and efficiency, ensuring full compliance and alignment with all applicable guidelines.
The process involves compiling and submitting ACTD/CTD dossiers, ensuring all documentation meets regulatory standards and timelines. This includes gathering technical, clinical, and quality data, organizing it into the required Common Technical Document (CTD) format, and finalizing submissions for approval by relevant health authorities. Proficiency in regulatory guidelines, meticulous attention to detail, and strong project management skills are essential to successfully execute these tasks and maintain compliance throughout the submission lifecycle.
We oversee the registration, renewal, and ongoing lifecycle management of products, ensuring compliance, efficiency, and seamless continuity throughout all stages of their development and deployment.
Regulatory engagement activities span across various African nations, involving interactions with local authorities and adherence to region-specific compliance frameworks.
Collaborate effectively with Chief Medical Officers, Contract Research Organizations, Quality Assurance, Research and Development, and Supply Chain teams to ensure seamless project execution and alignment of objectives.
The establishment and deployment of Risk and Information Management Systems (RIMS) and digital regulatory compliance platforms are to be carried out.
Leadership of teams, enhancement of capabilities, and management of performance
Seeking a highly motivated professional with exceptional organizational and communication skills to fill a critical role within our dynamic team. Candidates must possess a minimum of five years of relevant experience in [industry/field], along with a proven track record of delivering results in fast-paced environments. The ideal applicant will hold a [specific degree or certification, if applicable] and demonstrate proficiency in [key software, tools, or methodologies]. Strong problem-solving abilities, adaptability, and a commitment to continuous improvement are essential. Responsibilities include [list 2-3 key responsibilities, e.g., managing projects from inception to completion, collaborating with cross-functional teams, or analyzing data to drive strategic decisions]. Proficiency in [language, if required] and excellent interpersonal skills are also required to excel in this position.
Qualified applicants must possess the following prerequisites for this position:
A Bachelor’s degree in Pharmacy, Veterinary Medicine, Pharmaceutical Sciences, or a related scientific discipline is required for this role.
Professionals with a minimum of seven years of specialized experience in regulatory affairs within the pharmaceutical sector are required, particularly those with direct involvement in African markets.
Professionals must possess extensive expertise in compiling, submitting, and evaluating ACTD/CTD dossiers to ensure compliance with regulatory standards.
Proven expertise in managing product registrations, renewals, variations, and lifecycle oversight is required.
Experience in collaborating with domestic manufacturers and contract manufacturing organizations (CMOs) is highly desirable.
Proven experience in collaborating with Contract Research Organizations (CRO’s) to manage bioequivalence studies is strongly preferred.
Proficient in navigating pharmaceutical regulatory frameworks spanning various African nations.
Proficiency in regulatory systems, tracking tools, or RIMS platforms would be considered an asset.
Exceptional leadership capabilities, proficiency in managing stakeholders effectively, and a track record of successful cross-functional collaboration are essential for this role.
Please submit your CV to jobs@talentgridafrica.com to be considered for this position.
Qualifications
BA/BSc/HND
Experience Required
7 years
