Specialist, Regulatory Affairs at a multinational Pharmaceutical company - Adexen Recruitment Agency

Employment Nigeria 12-Aug-2017 LAGOS , Pharmaceutical

POSITION : Regulatory Affairs Specialist

Description

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
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.
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

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;
University Degree in Pharmacy
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;
Collaborative, team-oriented, flexible

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Specialist, Regulatory Affairs at a multinational Pharmaceutical company - Adexen Recruitment Agency

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