Regulatory Affairs Lead - AWA & Responsible Pharmacist at Bayer CropScience

Role Purpose

• Responsible and accountable for Company Regulatory Compliance and maintenance of company license to operate from Health Authority perspective.
• Responsible for the coordination of the registration, re-registration, life cycle management of Bayer Pharmaceuticals and Consumer Health Products in 5 countries Anglo West African countries. 
• Responsible Pharmacist for the Bayer Nigeria Ltd Entity, responsible for overall regulatory compliance of Pharmaceutical and Consumer Health Business, and single point of contact to the Health Authorities (NAFDAC and PCN) on behalf of the company
• Overall accountable for end-to-end regulatory oversight for all products marketed in the respective countries in Anglo West Africa region.

Key Responsibilities and Tasks

•  Responsible and accountable to lead regulatory strategies for all Bayer Pharmaceuticals and Consumer Health Products in AWA territory i.e. Nigeria, Ghana, Gambia, Liberia, Sierra Leone.
• Responsible and accountable to being well acquainted with and monitors current Anglo West Africa (AWA) countries Healthcare legislations, Health Authority regulations, guidelines, circulars, SOPs and other trade related regulations / requirements and timely informs Head of Regulatory Affairs and all departments on changes connected with product portfolio promotion and sales, taking the necessary regulatory actions.
• Responsible for the role of Responsible Pharmacist for the Bayer Nigeria Ltd as required by local law for operations of pharmaceutical company which entails the following responsibilities:
• As the sole spokesperson for the company towards health authorities in Nigeria
• Legally, and personally liable for all overall regulatory compliance of the company in Nigeria
• Decision maker, and to be consulted on all major company decisions in Nigeria, including staffing decisions for Pharmacist staff employed by Bayer Nigeria
• Coordinates all company responses to health authority, including those of other cross functions e.g. Pharmacovigilance, Medical Affairs, Quality Assurance
• Responsible to provide regulatory oversight of all CMO products and respective activities as conducted in Nigeria for selected Bayer products.
• Represents Bayer as a competent reliable partner to the AWA countries' Health Authorities in all regulatory matters. Builds regulatory networking with national regulators, local industry organizations and key opinion leaders. Supports and leads the contacts, submissions and communication with Health and other relevant Authorities and organizations participating in regulation of healthcare products in AWA countries.
• Leads the coordination of the activities of the regulatory affairs third party service providers for AWA countries in liaison with the other Bayer regulatory affairs personnel in Middle Africa
• Leads the acquisition and maintenance of Bayer Pharmaceuticals and Consumer Health products in the region, including overseeing the registration / re-registration and lifecycle management as defined by Head of Regulatory Affairs in Middle Africa and Commercial Lead.
• Responsible to lead regulatory business support activities in AWA by timely providing other departments with required regulatory input and documentation (e.g. copies of registration certificate, approved specification, description of packaging) such as market access and pricing approvals by the Health Authorities in the AWA territory
• Represents Regulatory Affairs in Senior Management of the country. Acts as interface to Commercial Lead Managing Director and head of Regulatory Affairs on country-related regulatory topics for marketed products
• Responsible to 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.

Qualifications, Skills and Competencies  

• University Degree in Pharmacy, additional business education qualification highly desirable
• Minimum 5 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.
• Collaborative, team-oriented, flexible
• Good command of English language (both oral
• Good Computer literacy.
• Readiness to business travel.