Regulatory Affairs Specialist at Adexen

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