Animal Health Regulatory Consultant (Must be NAFDAC accredited) at IQVIA

Reports to: Animal Health Regulatory Manager
Job Family: Medical Sales
Position Type: 2 Year Contract

Job Description

• IQVIA is expanding product portfolio in scope of African Livestock Productivity and Health Advancement Initiative (A.L.P.H.A.) therefore we are looking for Regulatory Professionals who can coordinate regulatory activities, locally.

Collaborates with:

• Operations Leads in A.L.P.H.A initiative regions of Nigeria
• NAFDAC
• Regional Regulatory Affairs Colleagues
• External collaborators and stakeholders including Distributors, initiative partners, NGOs, governmental organisations and other distribution initiatives Internal stakeholders.

Responsibilities

• 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, labeling and packaging requirements.

Qualifications

• B.Sc 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.