Regulatory Affairs Associate — Life Sciences (Hybrid)

PwC Belgium; Brussel Hoofdstad; Hybride; EUR 45 000 - 65 000; Plein temps

Avantages offerts par ce poste

Flexible hybrid work arrangements

Diverse training opportunities

Customizable rewards plan

Sustainable mobility

Résumé du poste

PwC Belgium seeks an Associate Regulatory Affairs Advisor with initial pharma or life sciences experience to support regulatory strategy and submissions. You will collaborate with multidisciplinary teams across the product lifecycle, navigating EMA and FDA guidelines to help our clients stay compliant and competitive.

The role emphasizes regulatory intelligence, health authority interactions, and exposure to RIM platforms, with opportunities for growth within PwC's Life Sciences practice in

Qualifications

• 1–2 years of Regulatory Affairs experience within pharma or life sciences.
• Practical exposure to EU pharmaceutical regulation, EMA procedures and/or National Competent Authorities.
• Exposure to regulatory submissions, lifecycle management, regulatory intelligence or Health Authority interactions.
• Exposure to Regulatory Affairs processes, systems or RIM platforms (e.g. Veeva RIM or similar).
• Knowledge of FDA and global regulatory processes is an advantage.

Responsabilités

• Navigate global regulatory requirements and identify practical solutions.
• Interpret EMA, FDA and National Authority requirements and guidance.
• Contribute to regulatory strategies, submissions and Health Authority interactions.
• Assist in regulatory information management solutions and process improvements.
• Support cross‑functional teams on regulatory activities across product lifecycles.
• Translate scientific data into clear, actionable regulatory insights.

Connaissances

Regulatory Affairs

EU Regulation

Regulatory Submissions

RIM/Lifecycle

FDA Knowledge

Analytical

Organisational

Communication

Problem-solving

Team Collaboration

English Fluency

Formation

Bachelor's or Master's in Pharmacy/Biomedical Sciences/Biology/Chemistry/Life Sciences

Regulatory Affairs Certification (TOPRA/DIA/RAPS)

Outils

Veeva RIM

Description du poste

PwC Belgium seeks an Associate Regulatory Affairs Advisor with initial pharma or life sciences experience to support regulatory strategy and submissions. You will collaborate with multidisciplinary teams across the product lifecycle, navigating EMA and FDA guidelines to help our clients stay compliant and competitive.

The role emphasizes regulatory intelligence, health authority interactions, and exposure to RIM platforms, with opportunities for growth within PwC's Life Sciences practice in