Hybrid Regulatory Affairs Specialist - Impactful Pharma

Placements24; Bloemfontein; Hybrid; ZAR 600.000 - 900.000; Vollzeit

Benefits dieser Stelle

Competitive salary

Medical aid

Retirement fund

Hybrid work model

Professional development

Public health impact

Zusammenfassung

Placements24 is partnering with a respected pharmaceutical company in Bloemfontein, Free State, to appoint a meticulous Regulatory Affairs Specialist in a hybrid role blending remote work with on-site collaboration.

You will prepare, submit, and manage regulatory dossiers with SAHPRA, FDA, and EMA, liaising with health authorities and internal teams to ensure compliant submissions and timely approvals.

Qualifikationen

• Bachelor’s degree in Pharmacy, Life Sciences, Chemistry, or related field.
• Minimum of 3 years of experience in pharma regulatory affairs.
• Experience preparing and submitting regulatory dossiers.
• Solid knowledge of SAHPRA, FDA, and EMA requirements.
• Excellent written and verbal communication.
• Strong attention to detail and organization.
• Proficiency in regulatory submission software and MS Office.
• Ability to work in a hybrid team and independently.
• Proactive approach to identifying regulatory challenges.

Aufgaben

• Prepare, review, and submit regulatory dossiers to health authorities (SAHPRA, FDA, EMA).
• Ensure submissions are accurate, complete, and compliant with guidelines.
• Maintain regulatory databases and tracking systems for submissions and approvals.
• Liaise with health authorities to respond to queries with required information.
• Monitor regulatory changes and assess impact on operations.
• Collaborate with R&D, manufacturing, and QA for submission data.
• Provide regulatory guidance to project teams during product lifecycle.
• Manage post-approval activities including variations and annual reports.
• Contribute to development and implementation of regulatory strategies.

Kenntnisse

Regulatory submissions

Pharma regulations

Documentation accuracy

Cross-functional collaboration

Communication

Ausbildung

Bachelor's degree in Pharmacy or Life Sciences

Tools

Regulatory software

Microsoft Office

Jobbeschreibung

Placements24 is partnering with a respected pharmaceutical company in Bloemfontein, Free State, to appoint a meticulous Regulatory Affairs Specialist in a hybrid role blending remote work with on-site collaboration.

You will prepare, submit, and manage regulatory dossiers with SAHPRA, FDA, and EMA, liaising with health authorities and internal teams to ensure compliant submissions and timely approvals.