This position plays a pivotal role in developing regulatory strategies, maintaining compliance, and facilitating the effective expansion of both human pharmaceutical and animal health products into new markets.
The ideal candidate will spearhead initiatives to drive organizational growth by overseeing strategic projects and ensuring alignment with long-term business objectives. They will manage cross-functional teams, fostering collaboration and accountability while delivering measurable results. Responsibilities include developing and implementing policies, optimizing processes, and mentoring staff to enhance performance and innovation.
Develop and implement strategic regulatory plans with precision and expertise. Formulate and oversee comprehensive regulatory frameworks to ensure compliance and facilitate seamless execution. Drive forward initiatives that align with organizational objectives and meet stringent regulatory standards.
We are seeking a meticulous professional to oversee the preparation and submission of ACTD/CTD dossiers, ensuring compliance with regulatory standards and timelines. This role requires expertise in compiling comprehensive documentation, including quality, non-clinical, and clinical sections, while coordinating with cross-functional teams to facilitate seamless submissions. Proficiency in navigating global regulatory requirements and maintaining meticulous attention to detail is essential to streamline the dossier lifecycle and support timely approvals.
The professional handles product registrations, renewals, and lifecycle management responsibilities.
Active involvement in regulatory liaison efforts spanning diverse African nations is required. This role entails navigating complex regulatory landscapes across multiple jurisdictions on the continent to ensure compliance and facilitate smooth operations. The position demands a thorough understanding of varied regulatory frameworks and the ability to adapt strategies to meet differing national requirements while maintaining alignment with overarching organizational objectives.
Collaboration with Chief Medical Officers, Contract Research Organizations, Quality Assurance, Research and Development, and Supply Chain departments is essential to ensure seamless project execution and regulatory compliance.
The development and deployment of Risk and Information Management Systems (RIMS) as well as digital regulatory compliance platforms represent a core responsibility of this role. Additionally, the successful candidate will be tasked with ensuring seamless integration of these systems with existing digital frameworks while maintaining full compliance with regulatory standards.
Experienced professionals adept at driving team success through strategic leadership, cultivating team capabilities, and optimizing performance outcomes are sought. The role demands a strong ability to inspire and guide teams, enhance collective competencies, and ensure consistent high-level results through effective management practices.
Key Responsibilities:
We are seeking an experienced professional to join our team, requiring a minimum of five years in a relevant field and proficiency in industry-specific tools or software. The ideal candidate must demonstrate strong problem-solving abilities, exceptional communication skills, and the capacity to work effectively in a collaborative environment. A bachelor’s degree in a related discipline is mandatory, along with certifications that may enhance your qualifications. You will be responsible for managing complex projects, ensuring adherence to deadlines, and maintaining high standards of quality in all deliverables. Additionally, you should possess leadership capabilities to guide teams, mentor junior staff, and drive operational efficiency. Prior experience in [specific industry or function] is highly preferred, as is familiarity with [specific regulations, frameworks, or methodologies]. This role demands adaptability, a commitment to continuous learning, and the ability to thrive under pressure while delivering measurable results.
To qualify for this position, applicants must meet the following criteria:
A bachelor’s degree in Pharmacy, Veterinary Medicine, Pharmaceutical Sciences, or a related scientific discipline is required for this position.
With a minimum of seven years of direct experience in regulatory affairs within the pharmaceutical sector, candidates should also demonstrate familiarity with the unique regulatory landscapes of African markets.
Proficiency in preparing, submitting, and reviewing ACTD/CTD dossiers is essential.
Seasoned professionals should demonstrate a strong background in overseeing product registrations, managing renewals, implementing variations, and guiding products through their entire lifecycle.
Individuals should possess hands-on experience collaborating with domestic manufacturers and contract manufacturing organizations (CMOs), with a preference given to candidates who have engaged with CMOs.
Experienced in managing collaborations with contract research organizations (CRO’s) to facilitate bioequivalence study coordination.
Proficiency in pharmaceutical regulatory frameworks spanning diverse African nations is essential, ensuring compliance with region-specific guidelines and standards.
Proficiency in regulatory frameworks, monitoring solutions, or RIMS platforms is beneficial.
Demonstrated expertise in guiding teams, cultivating influential relationships with stakeholders, and fostering seamless collaboration across diverse organizational functions.
Please submit your CV via email to talentgridafrica.com, with the subject line clearly marked as “Job Application – [Position Name].” Ensure your CV is attached in PDF format and includes a concise cover letter summarizing your qualifications and interest in the role.
Qualifications
BA/BSc/HND
Experience Required
7 years
