Global Regulatory Affairs Associate — Dossier Submissions & Compliance

Placements24; Bloemfontein; Hybrid; ZAR 400.000 - 700.000; Vollzeit

Benefits dieser Stelle

Competitive salary

Health, dental, vision insurance

Paid vacation and holidays

Professional development opportunities

Collaborative work environment

Zusammenfassung

Placements24 in Welkom is seeking a diligent Pharmaceutical Regulatory Affairs Associate to support compliance initiatives and ensure products meet local and international regulatory standards throughout their lifecycle.

You will assist in preparing and submitting regulatory dossiers, maintain filings, monitor evolving guidelines (ICH, FDA, EMA), and collaborate with R&D, manufacturing, and marketing to keep approvals on track.

Qualifikationen

• Bachelor's degree in Pharmacy, Life Sciences, Chemistry, or a related field.
• 1–3 years of experience in pharmaceutical regulatory affairs or a closely related field.
• Familiarity with global regulatory submission requirements (ICH, FDA, EMA).
• Strong understanding of drug development and pharmaceutical manufacturing principles.
• Excellent written and verbal communication skills with attention to detail.

Aufgaben

• Assist in the preparation, review, and submission of regulatory dossiers (e.g., CTD, IND, NDA).
• Maintain regulatory databases and ensure accuracy of product registration information.
• Monitor and interpret changes in regulatory requirements and guidelines impacting products.
• Liaise with regulatory agencies to respond to queries and facilitate approvals.
• Review labeling, promotional materials, and advertising for regulatory compliance.
• Collaborate with internal teams (R&D, Manufacturing, Marketing) to ensure regulatory requirements are met.

Kenntnisse

Regulatory affairs

Regulatory submissions

Attention to detail

Communication skills

Ausbildung

Bachelor's degree in Pharmacy, Life Sciences, Chemistry, or a related field

Jobbeschreibung

Placements24 in Welkom is seeking a diligent Pharmaceutical Regulatory Affairs Associate to support compliance initiatives and ensure products meet local and international regulatory standards throughout their lifecycle.

You will assist in preparing and submitting regulatory dossiers, maintain filings, monitor evolving guidelines (ICH, FDA, EMA), and collaborate with R&D, manufacturing, and marketing to keep approvals on track.