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 candidate will spearhead initiatives, overseeing key projects from inception to completion. They will manage cross-functional teams, ensuring alignment with organizational objectives and fostering collaboration among stakeholders. Additionally, the role entails driving strategic planning, optimizing processes, and implementing innovative solutions to enhance productivity and performance. Strong leadership, exceptional communication, and a results-driven mindset are essential for success in this position.
Developing and implementing regulatory strategies constitute a fundamental aspect of this role, encompassing the formulation of comprehensive plans and the effective execution of actions to ensure adherence to applicable laws, regulations, and industry standards. This process involves analyzing current and emerging regulatory requirements, identifying potential compliance risks, and proactively devising solutions to mitigate them while aligning with organizational objectives. The position demands a strategic approach to navigate complex regulatory landscapes, ensuring seamless integration of compliance measures into business operations while fostering sustainable growth and minimizing legal exposure.
Professionals in this role are responsible for compiling and submitting ACTD (Assembled DES Chefs de Defense) and CTD (Common Technical Document) dossiers, ensuring all documentation meets regulatory standards and submission requirements.
The product registration process includes handling new registrations, renewal requests, and managing the entire product lifecycle.
Regulatory engagement spans diverse African markets, ensuring compliance with regional and local requirements while fostering constructive dialogue with policymakers and authorities.
Collaborating effectively with Chief Medical Officers, Contract Research Organizations, Quality Assurance, Research & Development, and Supply Chain teams is essential to achieving project objectives.
The development and deployment of Regulatory Information Management Systems (RIMS) and digital regulatory platforms are integral responsibilities. This role entails configuring, integrating, and maintaining these systems to ensure compliance with evolving regulatory standards. Proficiency in RIMS architecture, data management, and regulatory technology solutions is essential for executing these tasks effectively.
We are seeking a leader who excels in guiding teams, fostering skill development, and driving performance excellence through effective management strategies. This role demands a strong ability to inspire and develop team members, enhance their capabilities, and ensure high standards of productivity and accountability. Prioritizing continuous improvement and aligning individual strengths with organizational goals will be essential to success in this position.
Key qualifications include a bachelor’s degree in a relevant field, a minimum of three years of hands-on experience in the specified industry, and proficiency with essential software tools. Candidates must demonstrate strong analytical skills, exceptional problem-solving abilities, and the capacity to work effectively in a fast-paced environment. Strong communication skills, both written and verbal, are essential for collaborating with cross-functional teams and stakeholders. Additionally, familiarity with industry regulations and compliance standards is required. The ability to manage multiple priorities while meeting deadlines is a must.
To qualify for this position, applicants must meet the following criteria:
A Bachelor’s degree in Pharmacy, Veterinary Medicine, Pharmaceutical Sciences, or a closely related scientific discipline is required.
Professionals with at least seven years of regulatory affairs expertise in the pharmaceutical sector, including familiarity with African markets, are encouraged to apply.
Experienced in preparing, submitting, and reviewing ACTD/CTD dossiers, with a proven track record in dossier management.
With a track record of successfully managing product registrations, renewals, variations, and lifecycle oversight, you bring valuable expertise to this role.
Professionals with expertise in locally manufactured products, as well as experience collaborating with Contract Manufacturing Organizations (CMOs), will be strongly considered. Familiarity with CMOs is particularly advantageous.
Experienced in managing bioequivalence studies in collaboration with contract research organizations (CRO’s), with a preference for prior involvement in such partnerships.
Proficiency in pharmaceutical regulatory frameworks spanning various African nations is essential.
Proficiency in regulatory systems, tracking tools, or RIMS platforms would be considered a valuable asset for this position.
Proven ability to lead teams, manage stakeholders effectively, and collaborate seamlessly across diverse functions.
Please submit your CV to jobs@talentgridafrica.com for consideration.
Qualifications
BA/BSc/HND
Experience Required
7 years
