Pharma Regulatory Affairs Specialist - Hybrid, Growth

Placements24; George; Hybrid; ZAR 700.000 - 1.100.000; Vollzeit

Benefits dieser Stelle

Competitive salary

Performance bonus

Health insurance

Retirement plan

Hybrid work model

Professional development

Zusammenfassung

Placements24 is seeking an experienced Regulatory Affairs Specialist to join our client’s team in George, Western Cape. You will prepare and submit regulatory filings, liaise with SAHPRA and other authorities, and drive lifecycle management for pharmaceutical products.

You will interpret evolving regulatory guidelines, collaborate with R&D, QA, and manufacturing, and implement strategic plans for product launches and market entries, ensuring compliance and product safety.

Qualifikationen

• Bachelor's degree in Pharmacy, Chemistry, Biotechnology or related field.
• Master's degree preferred.
• Minimum 4 years in pharmaceutical regulatory affairs.
• Strong knowledge of SAHPRA, FDA, EMA requirements.
• Proven experience preparing/regulatory filings.
• Excellent communication and project management skills.

Aufgaben

• Prepare, review, and submit regulatory dossiers (CTD, ANDA, NDA) to authorities.
• Interpret regulations and apply to product development and manufacturing.
• Manage product registrations and lifecycle activities (variations, renewals).
• Liaise with regulatory agencies and respond to queries.
• Develop regulatory strategies for launches and market expansion.
• Monitor regulatory changes and assess impact on operations.

Kenntnisse

Regulatory affairs

Documentation

Stakeholder liaison

Regulatory strategy

Ausbildung

Bachelor's in Pharmacy/ Chemistry/ Biotechnology

Master's degree preferable

Tools

Regulatory information systems

Jobbeschreibung

Placements24 is seeking an experienced Regulatory Affairs Specialist to join our client’s team in George, Western Cape. You will prepare and submit regulatory filings, liaise with SAHPRA and other authorities, and drive lifecycle management for pharmaceutical products.

You will interpret evolving regulatory guidelines, collaborate with R&D, QA, and manufacturing, and implement strategic plans for product launches and market entries, ensuring compliance and product safety.