Not specified
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 NAFDACÂ 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.
Apply via :
https://www.myjobmag.com/job/99940/animal-health-regulatory-consultant-must-be-nafdac-accredited-iqvia