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  • Posted: Jul 21, 2017
    Deadline: Not specified
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    Adexen is a global Human Ressources Company providing business services in Europe and Africa. We support companies in all industries in the fields of HR, Legal, Finance, Sales & Marketing, Engineering and Supply chain. We know how important people are to business. We also think that "People are the future of Africa" We understand what...
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    Regulatory Affairs Specialist

    Job Description

    • Monitors country requirements of registration and quality control of Healthcare products. Timely inform 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 company regulatory affairs functions
    • Supports contacts with Ministry of Health and other authorities and the organisations participating in registration, expertise and quality control of products;
    • Supports registration / re-registration of company 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 provide other departments with copies of registration certificate, approved specification, description of packaging, marking and maintenance aspects of the products;
    • 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 at Bayer;
    • Perform the role of responsible pharmacist for the company Nigeria 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 organisation 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 organisation
    • To ensure the registration and /or the re-registration of the company and Consumer Health 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 the withdrawal of products from the market; contributes to control the impact such issues can have on the company.
    • Exercises excellent judgment on critical drug quality and regulatory issues and optimal product quality and safety action based on pharmaceutical knowledge.
    • Ensure inspection preparedness, review departmental performance following defined targets and KPIs and take corrective actions as necessary.
    • Ensures Quality compliance within the country organisation.
    • Acts as decision-maker for all operational Quality matters in respective Quality country organisation
    • Ensures independent decision-making of Quality from business to avoid conflict of interest
    • The position holder has a 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.

    Expectations

    • 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;
    • Good command of English language (both oral and written)
    • Good Computer literacy;
    • Readiness to business travel;
    • Collaborative, team-oriented, flexible

    Method of Application

    Interested and qualified? Go to Adexen on www.adexen.com to apply

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