Pharmacist - Johannesburg, South Africa
- Harare, Zimbabwe
|Job Location||Johannesburg, South Africa|
|Employment Type||Full Time|
|Career Level||Senior Management|
|Years of Experience||6|
|Residence Location||Johannesburg, South Africa|
|Nationality||RSA Citizen or Work Permit Required|
Duties and Responsibilities;
* Registration of new products:
* Works in collaboration with the Corporate Head Responsible Pharmacist 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.
* 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.
* 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.
* Detailed understanding and knowledge of dosage requirements and administration, chemical compounds, and pharmaceutical brands.
* Working knowledge of Microsoft Office Suite and software applications, used by pharmacies, such as MEDITECH and MEDIWARE.
* Great organizational skills.
* Excellent verbal and written communication skills.
* Registration with the South African Pharmacy Council (SAPC) is essential.
* 3 - 5 years' experience in the Regulatory Affairs environment.
* Knowledge of current legislation governing product registration in SADC countries.
* Knowledge of other legal requirements impacting the regulatory environment e.g. advertising, GMP etc.
* Knowledge of pharmacology and therapeutics.
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