Regulatory Affairs Associate — Global Life Sciences

PwC South Africa; Brussel Hoofdstad; Hybride; Confidentiel; Plein temps

Avantages offerts par ce poste

Health insurance

Résumé du poste

PwC Belgium is seeking an Associate Regulatory Affairs Advisor to support clients in navigating European regulatory requirements and EMA procedures. You will help interpret guidance, contribute to submissions, and support Health Authority interactions within multi-disciplinary PwC teams.

The role requires 1–2 years in Regulatory Affairs, familiarity with EU regulation, and fluent English; knowledge of additional European languages is a plus.

Qualifications

• 1–2 years of Regulatory Affairs experience in pharma/biotech or life sciences.
• Experience with EU pharmaceutical regulation, EMA procedures or National Competent Authorities.
• Exposure to regulatory submissions, lifecycle management, regulatory intelligence or Health Authority interactions.
• Familiarity with Regulatory Affairs processes and RIM platforms (e.g., Veeva RIM).
• Strong analytical, communication and organizational skills; fluent in English; additional European languages are a plus.

Responsabilités

• Help clients navigate global regulatory requirements and identify practical solutions.
• Interpret EMA, FDA and National Authority guidance for regulatory strategies and submissions.
• Contribute to Health Authority interactions and client regulatory strategies.
• Assist with Regulatory Affairs processes, operating models and RIM implementations.
• Support multidisciplinary PwC teams across Life Sciences engagements.

Description du poste

PwC Belgium is seeking an Associate Regulatory Affairs Advisor to support clients in navigating European regulatory requirements and EMA procedures. You will help interpret guidance, contribute to submissions, and support Health Authority interactions within multi-disciplinary PwC teams.

The role requires 1–2 years in Regulatory Affairs, familiarity with EU regulation, and fluent English; knowledge of additional European languages is a plus.