This position plays a pivotal role in developing regulatory strategies, maintaining compliance, and facilitating successful market expansion for both human pharmaceutical and animal health products.
The ideal candidate will spearhead initiatives in the following areas:
Developing and implementing regulatory strategies form a critical component of this role, ensuring adherence to applicable laws and guidelines throughout all operational stages.
Expertise in compiling and filing ACTD/CTD dossiers is required.
We oversee the registration, renewal, and ongoing lifecycle management of products, ensuring compliance with regulatory standards and operational efficiency throughout each phase.
Responsible for managing regulatory interactions and compliance activities across various African countries, ensuring alignment with local and international standards while fostering productive relationships with relevant authorities.
Collaborate effectively with Chief Medical Officers (CMOs), Contract Research Organizations (CRO’s), Quality Assurance (QA), Research and Development (R&D) teams, and Supply Chain stakeholders to ensure seamless operational alignment.
The establishment and deployment of Risk and Information Management Systems (RIMS) and digital regulatory compliance platforms are included in the responsibilities.
Leadership of teams, development of capabilities, and management of performance
Key qualifications include a minimum of three years of relevant experience, a bachelor’s degree in a related field, and proficiency with industry-standard software such as Microsoft Office Suite or specialized tools pertinent to the role. Candidates must demonstrate strong analytical skills, attention to detail, and the ability to work independently as well as collaboratively in a team-oriented environment. Additional desirable attributes encompass excellent communication abilities, problem-solving acumen, and a commitment to continuous professional development. A valid driver’s license and willingness to travel occasionally may also be necessary, depending on the position’s demands.
To qualify for this position, applicants must meet the following criteria:
A relevant academic background, specifically a Bachelor’s degree in Pharmacy, Veterinary Medicine, Pharmaceutical Sciences, or an equivalent scientific discipline, is required.
With a minimum of seven years of regulatory affairs experience in the pharmaceutical sector, you have had direct involvement with African markets.
Proven expertise in the preparation, submission, and review of ACTD/CTD dossiers is required.
Seasoned professional with a strong track record in managing product registrations, ensuring timely renewals, implementing variations, and overseeing lifecycle management.
Seasoned professionals with a track record in collaborating with domestic manufacturers and contract manufacturing organizations—ideally CMOs—are encouraged to apply.
Seasoned in managing bioequivalence study collaborations with Contract Research Organizations (CRO’s) is highly desirable.
Proficient in navigating pharmaceutical regulatory frameworks spanning diverse African nations with a comprehensive understanding of regional compliance requirements.
Proficiency in regulatory systems, monitoring tools, or RIMS platforms would be considered a valuable asset.
Exceptional leadership abilities, adeptness in stakeholder engagement, and the capacity to collaborate effectively across diverse functions are required.
Please submit your CV to jobs@talentgridafrica.com.
Qualifications
BA/BSc/HND
Experience Required
7 years
