Snr Regulatory Affairs Pharmacist Job Johannesburg area,South Africa,Healthcare

Overview

Hire Resolve is seeking a Senior Regulatory Affairs Pharmacist to join our client’s team. As a Senior Regulatory Affairs Pharmacist, you will be responsible for ensuring compliance with regulatory requirements and managing the registration of pharmaceutical products.

Responsibilities

Prepare and submit regulatory applications for the registration of pharmaceutical products

Review and analyze regulatory documentation for accuracy and completeness

Develop and maintain relationships with regulatory authorities

Stay updated on changes in regulatory requirements and guidelines

Provide regulatory guidance and support to cross-functional teams

Ensure compliance with relevant regulations and standards

Participate in regulatory audits and inspections

Manage the maintenance and renewal of product registrations

Provide training on regulatory compliance and best practices

Conduct regulatory impact assessments for product changes and updates

Collaborate with global regulatory teams on international registration projects

Requirements:

B. Pharm (Bachelor of Pharmacy)

Registration with the South African Pharmacy Council (SAPC)

Minimum 5 years’ experience in Regulatory Affairs (must have experience with human medicine and biologicals)

Experience in product registration (NCE)

Maintenance of dossiers and updates

Pharmacovigilance experience/knowledge of collecting and reporting

Knowledge of SAHPRA submission portals

Launch procedures for new products

Knowledge and experience regarding QA processes, APQRs, customer complaints, etc.

In-depth knowledge of Regulations, Acts, and Guidelines for South Africa and East Africa related to dossier submissions and lifecycle management

Knowledge of the Marketing Code

Systems knowledge

Competent and experienced in eCTD submissions

Proficiency in Microsoft Office suite including Word, Excel, and PowerPoint at an Intermediate level

Familiarity with ZAZIBONA processes

Contact Hire Resolve for your next career-changing move.

Salary: negotiable.

Our client is offering a highly competitive salary for this role based on experience.

Alternatively, apply via our portal and email

Full Time

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