Job description
A top tier Multi National Pharmaceutical company and Global leader are now looking to hire a Regulatory Professional to be based in Nigeria, and report directly to the Regulatory Lead for SubSaharan Africa.The Regulatory Professional will support submissions, approvals and maintenance of Marketing Authorization Application (MAA) for projects in Nigeria. Other responsibilities will include:
Participate in project meetings with appropriate members of the EMEA Regulatory Affairs team.
Together with the EMEA Regulatory Leader provide both strategic and tactical regulatory support to Projects.
Act as primary point of contact with regulatory health authority and/or company appointed legal trade representative.
Assist with timely MAA availability, ensure that all document components are in place on time, identify and track critical path activities
Provide regulatory support throughout the registration process and the life-cycle of the product, including support to the company Distributor to ensure the timely follow up of approval applications. As well as acting as liaison between the Distributor and Internal Teams
Lead the transfer of Market Authorisation Holder Transfers in a timely and effective manner
Ensure appropriate and timely responses and follow-up to Health Authority comments and/or questions received.
Develop and ensure effective implementation of national regulatory strategies and tactics in support of the global development and life-cycle management plans.
Provide input for the PI based on an understanding of the implications of the regional regulatory strategy for labelling; Manages artwork; Ensure labelling compliance in the region and document it in the appropriate system.
Ensure appropriate electronic archiving of all communications from or to the Regulatory Agencies
Maintain planned and actual regulatory submission dates (including dossier submissions and Regulatory Agency responses) in the appropriate systems (eg SPS, MPD/PKB)
Contribute to standardisation/new systems and processes to ensure efficiency gains and to support continuity
Contribute to compliance with all regulatory requirements (e.g. timely submission of dossiers, post-marketing commitments, renewals, timely implementation of new national and international legislation, timely implementation and training of SOP’s & supporting systems).
Develop a deep understanding of the regional regulatory environment, competitor intelligence and disease area.
Act as the designated quality assurance pharmacist and provide, inter alia, effective management of product complaints, recalls, compliance (including artwork).
Required Qualifications Requirements
University degree – medical or paramedical (pharmacy, biology, veterinary etc.), or equivalent by experience 6-8 years related experience in pharmaceutical industry in Sub Saharan Africa, particularly in the Nigerian environment
Experience in some or all of the following pharmaceutical functions would be an advantage, particularly in Nigerian environment : regulatory, PV and quality.
Experience in managing third parties intermediaries or significant experience in working with third party regulatory intermediaries
Strong knowledge of general regulatory requirements and guidelines
Project teamwork and/or matrix organisation experience
Knowledge of and relationships with the Nigerian regulator
Skills
Ability to manage multiple tasks, projects, priorities,and complex systems simultaneously
Ability to work in a matrix organization and participate effectively both independently and as part of multiple teams
Project management skills
Strong Interpersonal and communication skills, supervisory skills, and presentation skills are a must
Fluency in English. Knowledge of French is highly preferred
Ability to work under strict timelines, combined with flexibility when emergency situations require this.
Knowledge of company standardised computer software
Ability for decision making, working under pressure, and exercising good judgment on special situations.
Capacity to be aware, abstract, analyze, calculate, catalogue, classify, compare, coordinate, copy, detect, diagnose, edit, estimate, evaluate, influence, inspect, instruct, interpret, read, measure, negotiate, observe, plan, group, organize, supervise, synthesise, and select
If you are looking for an exciting and new challenge based in Nigeria as a Regulatory Professional with a Global Multi National Pharmaceutical company, who are going through a period of growth then please send your CV to explore this opportunity further.
To apply, visit Kinetic Business Solutions FZ Career Page
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