Regulatory Affairs Associate — Life Sciences

PwC; Brussel Hoofdstad; Hybrid; EUR 45,000 - 65,000; Full time

Benefits offered by this job

Flexible hybrid work arrangements

Lifelong learning opportunities

Flexible rewards plan

Sustainable mobility

Job summary

PwC Belgium is seeking an Associate Regulatory Affairs Advisor with initial pharmaceutical or life sciences experience. You will support clients in navigating the evolving regulatory landscape, with exposure to EMA, FDA and major National Competent Authorities, working alongside multidisciplinary teams.

You will contribute to regulatory strategy and operational projects across the product lifecycle, including submissions and Health Authority interactions, and support regulatory information

Qualifications

• 1–2 years of Regulatory Affairs experience in the pharmaceutical, biotechnology or broader life sciences industry.
• 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) is an advantage.
• Knowledge of FDA and global regulatory processes is an advantage.
• Fluent in English; French, Dutch or other European languages are a plus.

Responsibilities

• Helping clients navigate global regulatory requirements and identify practical solutions to regulatory challenges.
• Interpreting EMA, FDA and National Competent Authority requirements and guidance.
• Contributing to client regulatory strategies, submissions and Health Authority interactions.
• Supporting assessments and improvements of Regulatory Affairs processes, operating models and systems, including regulatory information management (RIM) solutions.
• Helping clients understand the impact of new and evolving regulatory requirements on their products and activities.
• Turning regulatory and scientific information into clear, actionable insights and recommendations.
• Supporting broader Life Sciences client engagements, including projects spanning market access, health and regulatory policy, commercialisation and patient engagement, alongside multidisciplinary PwC teams.

Skills

Regulatory affairs

Regulatory submissions

Regulatory intelligence

Cross-functional collaboration

Fluent English

Education

Bachelor's or Master's degree in Pharmacy/Life Sciences

Tools

Veeva RIM

Job description

PwC Belgium is seeking an Associate Regulatory Affairs Advisor with initial pharmaceutical or life sciences experience. You will support clients in navigating the evolving regulatory landscape, with exposure to EMA, FDA and major National Competent Authorities, working alongside multidisciplinary teams.

You will contribute to regulatory strategy and operational projects across the product lifecycle, including submissions and Health Authority interactions, and support regulatory information