Head of Regulatory Affairs- Eac

4 weeks ago

Johannesburg, South Africa Abbott Laboratories Full time

**Head of regulatory - EAC**

**About Abbott**

Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.

**Working at Abbott**

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You will have access to:

- Career development with an international company where you can grow the career you dream of.
- A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
- A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

**The Opportunity**

This position works out of our Johannesburg offices, South Africa in the **Established Pharmaceutical Division **. In EPD, We are committed to bringing the benefits of our trusted medicines to more people in the world’s fastest-growing countries. Our broad portfolio of high-quality and differentiated branded generic medicines reaches across multiple therapeutic areas including gastroenterology, women's health, cardiometabolic, pain management/central nervous system, and respiratory.

As the **Head of Regulatory, EAC**, you will represents the company in dealings with the Registration and Pharmaceutical authorities and ensures compliance with applicable legislation.Directs, organizes and maintains the medicine registration function of the Established Pharmaceuticals Division across all countries within the English Africa Cluster;Advises on all forensic pharmaceutical matters related to these activities.Ensures alignment of department goals to that of the cluster as well as Regional Regulatory Affairs.Manages and oversees all activities conducted by regulatory team and regulatory consultants

**What You’ll Do**

**Core Responsibilities**:
**1.**Regulatory - Medicine** Registration **Function**:

- Provides guidance to regional product leads and commercial functions on regulatory strategies for new product registrations such as Geo-expansion projects and Licence & Acquisition deals.
- Oversees the compilation and submission of registration dossiers and the necessary additional documentation to relevant local Regulatory Authorities for the purpose of obtaining Marketing Approval in the countries under the responsibility of the English Africa Cluster by regulatory pharmacists and regulatory consultants as follows:
Evaluation, summarization and compilation of data to obtain approval where possible for new indications requested by Marketing.

**Regulatory - Life Cycle Maintenance**
- Oversees maintenance of products for marketability by the company for submitting and obtaining approval of planned and unexpected CMC changes including formulation changes, manufacturing changes, packaging changes and improved analytical methods to avoid stock ruptures and cancellation of registration.
- Oversees Labelling safety updates to ensure completion in line with global metrics and local requirements
- Oversees Licence Renewals, Retention & GMP renewal activities to ensure licence validity of all registered products before expiry date.
- Oversees Artwork creation and update activities for all printed packaging material for new product registrations and existing licences.
- Oversees licence cancellation and withdrawal activities in line with internal processes and NMRA requirements
- Oversees local and global regulatory projects to ensure regulatory milestones are met on time
- Oversees the management of Regulatory Risks to reduce and /or mitigate supply & compliance risks

**Regulatory - Rev**i**ew** **& Approval **o**f** **P**r**om**o**ti**onal** **Materi**al**:

- Oversees review and approval of promotional material to ensure compliance with the registration dossier, Abbott's Marketing Code as well as the relevant local Marketing Codes including the South African Code of Marketing Practices.

**Regulatory - Systems, Documentation, Records**
- Oversees regulatory databases and systems to ensure team training and compliance
- Oversees the update and maintenance of electronic documentation records to ensure secure accessibility to authorized stakeholders, for various platforms and folders.
- Ensures the protection of regulatory intellectual property by restricting access to authorized personnel
- Oversees local Regulatory SOP maintenance to ensure SOP’s / work instructions are available for all processes and complied with
- Ensures correct processes are followed for sample requests, legal documentation, payments.
- Oversees conversion of manual paper records to electronic records (scanning of dossiers).

**Regulatory - Man**a**gement** **of RA department**:

- Continually assesses and builds on leadership capabilities to effectively lead regulatory team and regulator

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