Snr Regulatory Affairs Portfolio Manager

6 months ago

Johannesburg, South Africa Abbott Laboratories Full time

**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 Roodepoort Offices, Abbott Place in the Established Pharmaceutical Division where 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 RA Manager/Snr RA Pharmacist, you will ensure new medicinal products are registered and existing registrations are maintained in accordance with current regulations of each country within the English Africa Cluster (EAC)

.**What You’ll Do**

**Registration of new products**:

- Works in collaboration with the Regional Product Lead (RPL) to proactively assess local submissions requirements, review & sign-off content for registration packages accordingly.

**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.
- Liaises with the NMRAs and appointed Agencies on new developments in the registration process, and ongoing activities for registered products.
- Communicates approvals from health authorities to relevant stakeholders
- Identifies and recommends opportunities for improvement to the existing processes, quality, systems, tools, and policies.
- Maintains written procedures are up-to-date.

**Maintaining existing registrations**:

- Compiles and submits technical amendments based on requests and data received from the registered manufacturing site and I or the RPL.
- Compiles and submits package insert amendments based on revised CCDS received by Area Labelling Coordinator.
- Reviews and approves new artwork and updates to artwork in line with regulatory requirements to be uploaded to the artwork system by RA associate
- Compiles and submits renewal packages for countries where this is required within the 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.
- **Liaising internally and with other departments**:

- **Management of quality documents relating to Regulatory Affairs processes**:

- **Deputy Responsible Pharmacist Responsibility**:

- Deputizes as Responsible Pharmacist in terms of Section 22 of the South African Pharmacy Act when requested to do so in the absence of the registered Responsible Pharmacist and accepts responsibility to the South African Pharmacy Council and SAHPRA for any act performed by or on behalf of the Company during such deputization.

**Required Qualifications**
- Bachelor of Pharmacy OR Health related degree is essential.
- Registration with the South African Pharmacy Council (SAPC) is advantageous

**Preferred Qualifications**
- 3 - 5 years' experience in the Regulatory Affairs environment
- 1 - 2 years' experience in regulatory activities having dealt with biosimiliars is Essential
- Exposure to the marketing of products in the pharmaceutical environments within the EAC
- Project and Portfolio Management
- Knowledge of other legal requirements impacting the regulatory environment e.g. advertising, GMP etc.
- Knowledge of pharmacology and therapeutics.

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

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