Regulatory Affairs Manager - Pharmaceutical at Adexen

Job Reference: 1414

Job Description

• The Regulatory Affairs Manager is responsible for ensuring that regulatory strategies and regulatory activities are effectively executed to meet the business objectives and legal requirements.

Responsibilities

• Create, maintain and supports contacts with Ministry of Health and other authorities and the organizations participating in registration, expertise and quality control of medicinal products in Nigeria; while Monitoring requirements of registration, quality assurance, 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.

Expectations

• A relevant university degree in Pharmacy
• Minimum of 8 years’ cognate experience in pharmaceuticals.
• Good knowledge of legislative and other standard documents in the sphere of registration and certification of pharmaceutical products
• Analytical and conceptual 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
• Readiness to business travel
• Good IT skills in MS Windows and Office.