This position plays a pivotal role in developing regulatory strategies, upholding compliance, and facilitating seamless market expansion for human pharmaceuticals and animal health products.
The ideal candidate will be responsible for spearheading and overseeing all facets of the assigned role, ensuring strategic alignment and operational excellence. This individual will serve as the primary driver of key initiatives, fostering collaboration across teams to achieve organizational objectives. Additionally, they will manage critical projects, mentor junior staff, and provide expert guidance to senior leadership. Strong leadership, exceptional communication skills, and a results-driven mindset are essential for success in this position.
Developing and implementing regulatory strategies form a core component of this role, requiring meticulous planning, coordination, and adherence to evolving compliance frameworks. This position demands a deep understanding of regulatory requirements and the ability to translate complex guidelines into actionable, strategic initiatives that ensure organizational compliance while supporting business objectives. Candidates must possess strong analytical skills to assess regulatory gaps, anticipate industry trends, and propose proactive solutions that mitigate risks and enhance operational efficiency. Additionally, the role involves collaborating with cross-functional teams, including legal, clinical, quality assurance, and manufacturing, to align strategic approaches with regulatory expectations and foster a culture of compliance throughout the organization.
Responsible for compiling, reviewing, and submitting ACTD/CTD dossiers, ensuring adherence to regulatory guidelines and timelines.
The position involves overseeing the registration, renewal, and ongoing lifecycle management of products. Responsibilities include ensuring accurate and timely processing of all product registrations and maintaining up-to-date records throughout each product’s lifecycle. Additionally, the role requires managing renewal processes and coordinating with relevant stakeholders to optimize product performance and compliance.
Engaging with regulatory authorities across various African nations forms a critical component of this role, requiring adept navigation of diverse legal and procedural landscapes to ensure alignment with local requirements and facilitate timely approvals.
Collaboration with Chief Medical Officers, Contract Research Organizations, Quality Assurance, Research & Development, and Supply Chain teams is essential.
The development and deployment of Regulatory Information Management Systems (RIMS) and modern digital regulatory platforms are required.
Skilled in leading teams, developing capabilities, and managing performance.
Seeking a candidate who meets the following essential qualifications: a minimum of three years of relevant work experience, proficiency in Microsoft Office Suite, strong analytical and problem-solving skills, excellent written and verbal communication abilities, and the capacity to work both independently and collaboratively in a fast-paced environment. The ideal applicant will demonstrate attention to detail, adaptability to changing priorities, and a commitment to delivering high-quality results. Additionally, prior experience in a similar role and familiarity with industry-specific regulations are highly desirable.
Candidates who wish to be considered for this position must meet the following criteria:
Bachelor’s degree in Pharmacy, Veterinary Medicine, Pharmaceutical Sciences, or a comparable scientific discipline is required.
With at least seven years of dedicated regulatory affairs experience in the pharmaceutical sector, including familiarity with African markets, candidates will be considered.
Proficiency in the preparation, submission, and review of ACTD/CTD dossiers is required, with a strong track record of experience in these areas.
Accomplished professionals with a track record in navigating product registrations, overseeing renewals, implementing variations, and managing lifecycle processes will find this opportunity compelling.
Experience with locally produced goods and contract manufacturing organizations (CMOs) is highly desirable.
With a preference for prior involvement in bioequivalence studies managed in collaboration with Contract Research Organizations (CRO’s), experience in this area is highly valued.
Adept knowledge of pharmaceutical regulatory frameworks spanning diverse nations within the African continent.
Proficiency in regulatory systems, monitoring tools, or RIMS platforms represents a valuable asset.
Demonstrated ability to lead teams effectively, manage key stakeholders, and foster productive cross-functional partnerships.
Please submit your CV to jobs@talentgridafrica.com for consideration.
Qualifications
BA/BSc/HND
Experience Required
7 years
