This position plays a pivotal role in developing regulatory strategies, upholding compliance standards, and facilitating seamless market expansion for human pharmaceutical and animal health products.
The ideal candidate will oversee and drive forward key initiatives, ensuring strategic alignment and operational excellence across all assigned responsibilities. They will spearhead critical projects, fostering collaboration and innovation while maintaining a clear focus on achieving measurable outcomes. Demonstrated leadership in managing cross-functional teams and a proven ability to navigate complex challenges will be essential, along with a track record of delivering high-impact results. Strong analytical, problem-solving, and communication skills will be required to effectively engage stakeholders and drive sustainable growth.
Responsible for developing and implementing regulatory strategies, ensuring alignment with applicable laws, guidelines, and industry standards to facilitate smooth compliance processes and achieve organizational objectives.
Proactively develops and compiles ACTD/CTD dossiers, ensuring meticulous preparation and timely submissions for regulatory approvals.
Handle product registrations, manage renewals, and oversee lifecycle processes to ensure seamless operation and compliance throughout each stage.
Engaging with regulatory bodies across various African nations is essential to ensure compliance and foster strategic partnerships. This role involves collaborating with diverse stakeholders to navigate complex regulatory landscapes, staying abreast of evolving policies, and advocating for the organization’s interests. Responsibilities include liaising with government agencies, industry regulators, and policymakers to align business practices with local and regional requirements while mitigating risks and capitalizing on opportunities. Strong interpersonal and negotiation skills, along with a deep understanding of African regulatory frameworks, are critical for success in this position.
Collaboration with Chief Medical Officers, Contract Research Organizations, Quality Assurance, Research & Development, and Supply Chain teams is required.
The establishment and integration of Regulatory Information Management Systems (RIMS) alongside advanced digital regulatory platforms are required to ensure compliance and operational efficiency.
Provides leadership to the team, cultivates individual capabilities, and oversees performance management to ensure optimal outcomes.
Candidates must meet the following essential qualifications and professional standards to be considered for this role. A minimum of five years of relevant experience in the field is required, along with a bachelor’s degree or higher in a related discipline. Proficiency in industry-standard software and tools is mandatory, and strong analytical, communication, and problem-solving skills are necessary. Additionally, the ability to work independently and collaboratively in a fast-paced environment is expected. Familiarity with regulatory guidelines and compliance standards is also a prerequisite for this position.
Candidates interested in this opportunity must meet the following prerequisites:
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 in the pharmaceutical sector, you have gained substantial exposure to African markets.
Proven expertise in the preparation, submission, and review of ACTD/CTD dossiers is required for this role.
Accomplished professionals with a demonstrated track record in managing product registrations, handling renewals, addressing variations, and overseeing lifecycle operations are encouraged to apply.
Professionally experienced with locally produced goods and contract manufacturing organizations (CMOs), with relevant work history strongly preferred.
Experienced in managing the coordination of bioequivalence studies in collaboration with Contract Research Organizations (CRO’s), with a preference for prior engagement in such partnerships.
Proficiency in pharmaceutical regulatory frameworks spanning various African nations is required, demonstrating a comprehensive understanding of the distinct regulatory landscapes across the continent.
Proficiency in regulatory information management systems (RIMS) or tracking tools, as well as familiarity with regulatory frameworks, will strengthen your application.
Exceptional leadership abilities, adept stakeholder engagement, and seamless cross-functional collaboration are essential.
Please submit your CV to jobs@talentgridafrica.com for consideration.
Qualifications
BA/BSc/HND
Experience Required
7 years
