Adexen Recruitment Agency is mandated by a multinational company with core competencies in the fields of health care, agriculture and high-tech polymer materials to recruit a regulatory affairs specialist – Health care for its operations in Nigeria This position is based in Lagos- Nigeria
Our client is one of the world's leading, innovative companies in the healthcare and medical products industry.
Create, maintain and supports contacts with Ministry of Health and other authorities and the organisations participating in registration, expertise and quality control of medicinal products in Nigeria; while Monitoring requirements of registration, quality assurance and product maintenance of medicinal products and informing in a timely manner the Head of Regulatory Affairs and all departments on changes connected with product portfolio promotion and sales.
Carry out all activities pertaining to registration and maintenance of product portfolio of the company, subsidiaries and if necessary company partners as defined by Head of Regulatory Affairs.
Business support of the Representation offices in Nigeria as necessary by providing documents, registration certificates, NDA, leaflets, packaging material, tender business support.
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 the company Healthcare in Nigeria.
Participates in development and implementation of packaging, labelling, application instructions and insert (checks conformity of NDA and, if necessary, put relevant corrective amendments in place), as well as providing the links between Product supply and Regulatory Affairs functions
Supports projects of business units through review and approval of promotional material; ensuring compliance of the company promotional material with the company and local country requirements
Ensuring product supply chain compliance as well as the local quality representation
Act as the responsible pharmacist for the company Nigeria office
A relevant university degree in Pharmacy
Minimum of 3 - 4 years experience in medical products registration
Good knowledge of legislative and other standard documents in the sphere of registration and certification of pharmaceutical products
Analytical and conception thinking;
Have demonstrated ability to produce timely results that are of high quality and accuracy
Have strong communication skills and able to work closely with people in wide variety of disciplines at different levels within the organization
Capable of representing the interests of the company effectively to a range of regulatory agencies and government officials
A self-starter, systematic, hands-on and thorough with a goal oriented mindset
Knowledge in developing protocols and analyzing data reports for registration requirements
Have experience of compiling accurate and complete preparation of registration dossiers
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