Vacancy at Workforce Group for Regulatory Affairs Specialist

Employment Nigeria 19-May-2017 LAGOS , Administrative Pharmaceutical

POSITION : Regulatory Affairs Specialist

Responsibilities

Ensures adherence to industry-specific codes of practice or conduct, advertising codes, regulatory directives and guidelines, as applicable to the role, and to the Program for Legal Compliance and Corporate Responsibility.
Perform the role of responsible pharmacist for the client’s Office in Lagos;
Responsible for the oversight of quality processes (e.g. GMP/GDP) and their implementation within the country platform.
Maintains local Quality Management System (in line with local regulations and global QMS)
Represents Quality in Senior Management of the country (e.g. QMR)
Leads the Quality country organization and has interlinkage to local functions performing quality (e.g. GDP/GMP) relevant processes (e.g. SCM)
Acts as interface to Managing Director and Cluster Quality Head on country-related Quality topics for marketed products
Ensures quality training (e.g. GMP /GDP) for the local organization
To ensure the registration and /or the re-registration of the client’s products in Nigeria.
Assures license to operate in the countries
Contributor to decision making process involving business critical action regarding product quality and regulatory issues and crises.
Provides Regulatory and Quality Assurance expertise to cross functional groups including legal counsel.
Enhances good communications and collaboration between all internal and external customers, while at the same time ensuring that the highest Regulatory and Quality standards are maintained.
Remains current with changing regulatory requirements, ensuring company compliance with current legislation and regulatory demands.
Influential in withdrawal of products from the market; contributes to control the impact such issues can have on the company.
Exercises excellent judgement on critical drug quality and regulatory issues and optimal product quality and safety action based on pharmaceutical knowledge.
Monitors country requirements of registration and quality control of Healthcare products. Timely informs Head of Regulatory Affairs and all departments on changes connected with product portfolio promotion and sales;
Coordinate the activities of the regulatory affairs third party service provider in liaison with the other regulatory affairs functions
Supports contacts with Ministry of Health and other authorities and the organizations participating in registration, expertise and quality control of products;
Supports registration / re-registration of the client’s product portfolio, subsidiaries
If necessary companies-partners defined by Head of Regulatory Affairs in Middle Africa;
Provides regularly progress reports, puts regulatory dates together and supports entry into databases in liaison with the regional office in Nairobi;
Participates in development of country packing, labelling, application instructions and insert (checks conformity of NDA and, if necessary, puts relevant corrective amendments in place);
Timely provides other departments with copies of registration certificate, approved specification, description of packaging, marking and maintenance aspects of the products;
Ensure inspection preparedness, review departmental performance following defined targets and KPIs and take corrective actions as necessary.
Ensures Quality compliance within country organization.
Acts as decision-maker for all operational Quality matters in respective Quality country organization
Ensures independent decision-making of Quality from business to avoid conflict of interest
The position holder has direct influence on the country’s EBIT by preventing major authority enforcements due to non-GMP/GDP compliance. Such enforcements can easily result in financial damage and severe loss of reputation at authorities, patients and customers.

Who We Are Looking For

Good command of English language (both oral and written)
Good Computer literacy;
Readiness to business travel;
Collaborative, team-oriented, flexible
University Degree in Pharmacy
Minimum 3 years of work experience in Quality Control, Product Development or Regulatory Affairs;
Good knowledge of regulatory environment in the sphere of registration and certification of pharmaceutical products;
High self-motivation to complete processes even in challenging regulatory environment;

Purpose

Accountable for end-to-end Quality oversight for all products marketed in the respective countries
Accountable for Quality oversight for Good Distribution Practice (GDP) processes and their implementation within the countries
Coordination of the registration, re-registration, life cycle management, and Regulatory compliance of the client’s Products in Anglo West Africa Countries (Nigeria, Ghana, Liberia, Sierra Leone and Gambia)
Act as responsible Pharmacist for the client’s Office in Nigeria
Responsible for an efficient local Quality Management System and compliant Quality process execution within Quality Country platform organization

How To Apply
Candidates should forward their CV's to:jobs@wfmcentre.com using 'Regulatory Affairs Specialist' as the subject

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Vacancy at Workforce Group for Regulatory Affairs Specialist

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