Snr Regulatory Affairs Portfolio Manager

4 weeks ago

Johannesburg, South Africa Abbott Full time

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.

•Conducts dossier due diligence to ensure all data gaps are addressed in preparation for new registration applications.

•Prepares the registration applications for submission to the NMRA in conjunction with the relevant RPL’s.

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:

•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.

•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.

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