Animal Health Regulatory Agent – IQVIA Tanzania
IQVIA is looking for Animal Health Regulatory Agent to be part of our team in Tanzania working on the African Livestock Productivity and Health Advancement Initiative (A.L.P.H.A.) project, with the ability to coordinate local regulatory activities. Successful candidate will need to have previous experience working with the NAFDAC and product registration. This will be a part-time/ fixed term role pending the outcome of the project.
Role Key Objectives:
Reports to: Regional ALPHA Regulatory Manager
Education, Qualifications & Experience:
• BSc in Veterinary Medicines or related fields
• Consultant accredited by NAFDAC
• At least 7 Years direct NAFDAC experience
• Excellent knowledge of local requirements
• Effective organizational skills
Setting ambitious targets while knowing how to take risks, initiative, customer focused, ability to function effectively within a team + to lead a team, people oriented, innovation, culturally sensitive and strategic thinker. Demonstrable high performance with a high drive & energy. Integrity, innovation and adaptability & building team cohesion are key.
Substantial knowledge & understanding of the pharmaceutical industry and the factors impacting sales / trends
Extended knowledge of the company’s own products + competitors
Ability to plan and execute in a given time frame
Understanding of the budgeting and forecasting processes, a clear grasp of marketing strategies and processes, negotiation skills, ability to establish / lead a high performing sales team and communication skills. Sales & market analysis. Ability to translate marketing strategies into actionable points for sales team & implementation. Proven leadership skills.
-Operations Leads in A.L.P.H.A initiative regions of Tanzania.
-Regional Regulatory Affairs Colleagues
-External collaborators and stakeholders including Distributors, initiative partners, NGOs, governmental organisations and other distribution initiatives
The Regulatory Affairs Consultant will develop relationships with representatives of NAFDAC to ensure effective communication and co-operation
– Responsible for supporting Regulatory Affairs domestically
– Submission of new product registrations including adaption of global dossier to local format
– Submission of renewals and variations
– Participate in workshops and meetings organized by NAFDAC
– Coordinate response to questions in timely manner
– Tracking of submissions
– Ensure that a company’s products comply with the regulations of the regions where they want to distribute them
– Keep up to date with national and international legislation, guidelines and customer practices
– Collect, collate and evaluate scientific data from a range of sources
– Develop and write clear arguments and explanations for new product licences and licence renewals
– Prepare submissions of licence variations and renewals to strict deadlines
– Monitor and set timelines for licence variations and renewal approvals
– Work with specialist computer software and resources
– Advise stakeholders and manufacturers on regulatory requirements
– Provide strategic advice to senior management throughout the registration of a new product
– Undertake and manage regulatory inspections
– Liaise with, and make presentations to, regulatory authorities
– Negotiate with regulatory authorities for marketing authorisation
– Specify storage, labelling and packaging requirements.
Objectives of ALPHA Project:
• Investment in sustainable collaborative business and supply networks that will lead to a thriving animal health and related business community.
• Improved availability of our clients veterinary medicines through importation permits and product registration in selected countries to extend the number of disease interventions available to treat livestock diseases.
• Adaption of the product packaging and manufacturing to ensure the requirements of smallholder farmers are met for smaller product volumes packaged in the most cost-efficient manner.
• Local distribution network improvement to go the ‘last mile’ to reach the small holder community.
• Improved livestock health and productivity through the reduction of animal diseases
• Development of a sustainable diagnostic infrastructure to improve the correct diagnosis of livestock production diseases affecting farmers in sub-Saharan Africa
• Provision of a full consultancy service to complement diagnostic results and recommend appropriate medicine use and biosecurity measures to maximize the effectiveness of control measures
• Supporting local veterinarians and relevant veterinary authorities in implementing livestock vaccination programs by supplying relevant high-quality vaccines and technical bulletins and services
• Delivery of outreach clinics to improve medicalization of remote farming communities and to deliver relevant education to help increase profitability of small-holders and overall livestock farming
Estimated Percentage of Travel: Candidate will be expected to travel.
Candidates who meet the criteria, to please liase with Thapi Mokose to discuss the role further on Mmathapelo.Mokose@quintiles.com or +27 0126712277.
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Animal Health Regulatory Agent – IQVIA Tanzania