Adexen Recruitment Agency – Our client is a multinational Pharmaceutical company that specialises in researching, developing and marketing specialty-focused innovative medicines.
We Are Recruiting To Fill The Position Below
Job Title: 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
Application Closing Date
Not Specified.
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