Radiology Applications Specialist (Durban)

Greys Recruitment; Sudáfrica; Presencial; ZAR 600.000 - 900.000; Jornada completa

Descripción de la vacante

Greys Recruitment is seeking a qualified Pharmacist with SA regulatory affairs expertise to assume the Responsible Pharmacist role and oversee compliance with SAHPRA and SAPC requirements.

The role focuses on compiling CTD/eCTD submissions, keeping licenses up to date, and ensuring GMP/GWP compliance across the distribution chain. Strong documentation and liaison skills are essential.

Formación

• B.Pharm degree with SAPC registration in good standing.
• Minimum 2 years of regulatory affairs experience in SA human medicines.
• Experience independently compiling and submitting SAHPRA CTD/eCTD dossiers.
• Hands-on experience with DocuBridge for eCTD compilation/publishing.
• Willing to be appointed as the company’s Responsible Pharmacist.
• Strong knowledge of Pharmacy Act, SAPC rules, Medicines Act and GWP.

Responsabilidades

• Fulfil statutory responsibilities of the Responsible Pharmacist per Pharmacy Act and SAPC rules.
• Ensure premises registration and pharmaceutical licences remain current.
• Oversee GWP including receipt, storage, handling and distribution of medicines and cold-chain products.
• Maintain records of scheduled substances and manage recalls, quality complaints and ADR reporting.
• Coordinate SAHPRA/SAPC inspections and staff training on GWP and compliance.

Conocimientos

Regulatory affairs

CTD/eCTD

Documentation

SAPC knowledge

Educación

B.Pharm degree

Herramientas

DocuBridge

Descripción del empleo

MINIMUM REQUIREMENTS

• B.Pharm degree.
• Current registration and good standing with the South African Pharmacy Council (SAPC).
• Minimum of 2 years' pharmaceutical regulatory affairs experience within the South African human medicines environment.
• Proven experience independently compiling and submitting new product registration dossiers to SAHPRA.
• Working knowledge of CTD/eCTD requirements, SAHPRA guidelines and the SAHPRA submission portal.
• Hands-on experience with DocuBridge for eCTD compilation and publishing.
• Eligible and willing to be appointed as the company's Responsible Pharmacist.
• Sound knowledge of the Pharmacy Act, SAPC rules, Medicines and Related Substances Act and Good Wholesaling Practice (GWP).
• Experience with product variations, renewals and responding to SAHPRA queries.
• Valid driver's licence.

ADVANTAGEOUS EXPERIENCE

• Previous experience as a Responsible Pharmacist, preferably within a pharmaceutical wholesale or distribution environment.
• Experience across various therapeutic areas.
• Experience working with international manufacturers and reviewing regulatory dossiers.
• Knowledge of international GMP and regulatory standards.
• Medical device regulatory experience.
• Exposure to commercial processes requiring regulatory documentation.

KEY RESPONSIBILITIES

Responsible Pharmacist & Compliance

• Fulfil the statutory responsibilities of the company's Responsible Pharmacist in accordance with the Pharmacy Act and SAPC rules.
• Ensure the company's premises registration and relevant pharmaceutical licences remain current.
• Oversee Good Wholesaling Practice (GWP), including the receipt, storage, handling and distribution of medicines and cold-chain products.
• Ensure only appropriately registered and authorised products are distributed.
• Maintain control and records of scheduled substances.
• Manage product recalls, quality complaints and adverse drug reaction reporting.
• Coordinate and support SAHPRA and SAPC inspections.
• Provide staff training on GWP and pharmacy compliance requirements.
• Notify the relevant regulatory authorities of changes as required.

SAHPRA Applications & Product Registrations

• Compile, review and submit new product registration dossiers to SAHPRA in CTD/eCTD format.
• Review dossiers received from manufacturers and partners for completeness and South African regulatory compliance.
• Prepare responses to SAHPRA queries, deficiency letters and committee recommendations.
• Monitor submission progress and liaise with SAHPRA regarding outstanding applications.

Product Lifecycle Management

• Manage and support post-registration variations, amendments, renewals and annual retention fees.
• Maintain approved package inserts, patient information leaflets and product labelling artwork.
• Assess regulatory implications of manufacturer changes, including manufacturing sites, formulations and product specifications.

Licensing & Regulatory Compliance

• Support applications and amendments for company licences under the Medicines and Related Substances Act, including Section 22C licences.
• Maintain compliance with the Medicines Act, Pharmacy Act, SAPC rules and applicable SAHPRA guidelines.
• Support GMP/GWP compliance, supplier qualification, audits and inspections.
• Maintain accurate regulatory records, submission trackers and documentation.

Medical Devices & Regulatory Intelligence

• Support SAHPRA medical device licensing and product listing requirements where applicable.
• Monitor regulatory developments in South Africa and other relevant African markets.
• Maintain professional working relationships with SAHPRA and international regulatory partners.

CORE COMPETENCIES

• High levels of integrity, professionalism and confidentiality.
• Exceptional attention to detail and accuracy.
• Strong written and verbal communication skills.
• Ability to work independently and manage multiple regulatory submissions.
• Excellent organisational and deadline-management skills.
• Commercial awareness and understanding of the impact of regulatory timelines on business operations.
• Proficiency in MS Office and document management systems.

REMUNERATION: Negotiable and market-related, commensurate with qualifications and experience.

PLEASE NOTE:

This is an office-based position working hours of 08h00 – 17h00, Monday to Friday.