Division: Abbott Established Pharmaceuticals Division
Reports to: Head of Regulatory Affairs
Primary Objective of Position:
• 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).
• Ensure promotional material for marketed products complies with the relevant product registration and country-specific Codes of Marketing Compliance.
• Ensure compliance to Abbott Global and Regional Regulatory Affairs Quality Systems, policies, and procedures.
• 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:
• Business Development, Quality Assurance, Medical, Pharmacovigilance, Sales & Marketing , Operations .
• Management of quality documents relating to Regulatory Affairs processes:
• Ensures compliance to EPD Global & Regional RA Quality Systems, policies, and procedures.
• 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 .
Qualifications and experience required:
• Bachelor of Pharmacy degree is essential
• Registration with the South African Pharmacy Council (SAPC) is essential
• Courses in Medicine Registration, Marketing Code & Advertising of medicines and other related subjects.
• A tertiary qualification in a management discipline is an advantage
• 3 - 5 years' experience in the Regulatory Affairs environment
• 1 - 2 years' experience in regulatory activities in English & Portuguese speaking African countries
• Exposure to the marketing of products in the pharmaceutical environments within the EAC
• Project and Portfolio Management
• Knowledge of current legislation governing product registration in English & Portuguese speaking African countries.
• Knowledge of other legal requirements impacting the regulatory environment e.g. advertising, GMP etc.
• Knowledge of pharmacology and therapeutics.
• Knowledge of the Abbott organization, policies, and procedures
Please note this role is for a future hire,
South Africa > Johannesburg : Abbott Place
Yes, 25 % of the Time
SIGNIFICANT WORK ACTIVITIES: