Snr Regulatory Affairs Portfolio Manager

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About the role

JOB DESCRIPTION: JOB DESCRIPTION Job Title Senior Regulatory Affairs Portfolio Manager Job Purpose and Scope Ethical & legal responsibilities: • • Build relationships with key stakeholders and represent Abbott in an appropriate manner according to company values, in order to present Abbott policies and strategies. • • Keep abreast with new developments in legislation, guidelines and regulations of the NMRAs in the countries within scope of responsibility, and cascade these locally and globally within the organization. • • Ensure compliance to Abbott Global and Regional Regulatory Affairs Quality Systems, policies and procedures. • • Manage regulatory associates, regulatory consultants and regulatory team members for regulatory projects and activities as required, • • Liaises with external stakeholders on regulatory matters as required. • • Responsible for ensuring that new products are registered and existing registrations are maintained in accordance with the current requirements of the National Medicine Regulatory Authorities (NMRA) of each country within the English Africa Cluster (EAC). • • Ensure that promotional material for marketed products comply with the relevant product registration and any country-specific Codes of Marketing Compliance. Core Job Responsibilities Core Responsibilities: 1. Registration of new products: • • Provides guidance on regulatory strategies and requirements for new NPI opportunities / projects. • • Works in collaboration with the Regional Product Lead (RPL) to proactively assess local submissions requirements, review & sign-off content for registration packages accordingly. • • Conducts dossier due diligence to ensure all data gaps are addressed in preparation for new registration applications. Abbott Laboratories S.A. (Pty) Ltd JOB DESCRIPTION • • Prepares the registration applications for submission to the NMRA in conjunction with the relevant RPL's. • • Orders samples and other relevant data as per local requirements and internal processes. • • Prepares the submission of appeals to negative responses and responses to deficiency letters received from the NMRA, in a timeous manner. 2. Maintaining existing registrations: • • • Maintains existing product registrations in line with current legal and internal requirements for allocated portfolio of products • • Prepares and submits technical updates based on the review of current data versus data contained in the registration application. • • Compiles and submits technical amendments based on requests and data received from the registered manufacturing site and I or the RPL. Requests data required to do the technical updates from the RPL. • • Compiles and submits package insert amendments based on revised reference labels received by Area Labelling Coordinator. • • Follows up with the local distributor or Health Authority for submissions pending approval. • • Reviews and approves new artwork and updates to artwork in line with regulatory requirements to be uploaded to artwork system by RA associate. • • Ensures compliance of printed packaging components with updated regulations and corporate branding requirements. • • Compiles and submits renewal packages for countries where this is required within agreed timelines to ensure no loss of registration license. • • Reviews and approves promotional material for marketed products to ensure compliance with the relevant product registration and any country-specific Code of Marketing Compliance. 3. Legislation, Regulatory Authorities & Process Improvement: • Keeps abreast of new developments in legislation, guidelines and regulations of the NMRAs, interprets and cascades these locally and globally within the organization. • Manages and monitors changes in the regulatory landscap

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