Junior Regulatory Affairs Advisor

PRICEWATERHOUSECOOPERS ENTERPRISE ADVISORY BV/SRL; Brussel Hoofdstad; Hybride; EUR 45 000 - 65 000; Plein temps

Avantages offerts par ce poste

Flexible hybrid work arrangements

Lifelong learning opportunities

Flexible rewards plan

Sustainable mobility

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

Regulatory affairs

Regulatory submissions

Regulatory intelligence

Cross-functional collaboration

Fluent English

Formation

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

Outils

Veeva RIM

Description du poste

Job Description & Summary

Line of Service Advisory Industry/Sector Not Applicable Specialism Customer Management Level Associate Job Description & Summary Contribute to creating a better tomorrow The only way we can tackle the challenges of this fast-changing world is with passionate people. Led by our purpose of building trust and solving important problems, we come together at PwC to address the biggest issues facing the world in a way that drives positive impact. Are you eager to join a team fuelled by open and curious minds? People who are passionate about their work and create new solutions for a new day? Then you’re at the right place. Bring your talent. Learn new skills. Make a positive impact. PwC Advisory is a garden of possibilities, and you’re reaping the rewards. Where you want to make an impact is always up to you. With the full support of our Advisory teams, you’ll delve into the inner workings of companies to find the best solutions for any challenge they might have. From the excitement of deals to the complexities of consulting and the fascinating realm of risks and threats in forensics, you’ll help clients nurture trust and maintain their evolutionary edge, today and into the future. Now that’s making a difference. Within our Life Sciences practice, we are looking for an Associate Regulatory Affairs Advisor with initial pharmaceutical or life sciences industry experience. You will support clients in navigating the evolving regulatory landscape, with exposure to EMA, FDA and major National Competent Authorities. Working alongside experienced colleagues and multidisciplinary teams, you will contribute to regulatory strategy and operational projects across the product lifecycle.

Your impact

• Helping clients navigate global regulatory requirements and identify practical solutions to regulatory challenges;
• Supporting clients in 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.

About you

• 1–2 years of Regulatory Affairs experience within 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;
• Bachelor's or Master's degree in Pharmacy, Biomedical Sciences, Biology, Chemistry, Life Sciences or a related scientific discipline;
• Regulatory Affairs training, professional development or certification from recognised organisations such as TOPRA, DIA or RAPS is a plus;
• Strong analytical, organisational, communication and problem‑solving skills;
• A curious, collaborative and client‑focused mindset, with an interest in developing expertise across Regulatory Affairs and the broader Life Sciences sector;
• Ability to work effectively across multidisciplinary and international teams and manage multiple priorities;
• Fluent in English is required;
• French, Dutch or other European languages are a plus.

Life at PwC Belgium

• Flexible work patterns: Achieve the perfect balance between office and home life with our flexible hybrid work arrangements and family‑friendly schemes.
• Lifelong learning: Grow with us! Take advantage of our diverse training opportunities and exciting career pathways to explore new disciplines and expertise.
• Flexible rewards: Tailor your benefits to suit your lifestyle with our customizable rewards plan.
• Sustainable mobility: Choose eco‑friendly mobility options, from our soon‑to‑be fully electrified fleet to public transport, shared cars, ebikes, and more.
• Inclusive culture: Thrive in a diverse, inclusive workplace that values and celebrates every individual's contributions.
• Wellbeing focus: Enjoy a positive environment with our comprehensive wellbeing programs, engaging sports communities, and confidential support for all your professional and personal challenges.
• Global network: Expand your horizons with opportunities to work abroad and tap into extensive industry expertise within the PwC network.

Equal Opportunity Employer statement

At PwC, we are dedicated to building a diverse, inclusive, and authentic environment. We are committed to providing equal employment opportunities for all candidates and employees, regardless of race, religion, gender identity or expression, sexual orientation, national origin, age, disability, marital status, or any other characteristic protected by law. We believe that a diverse and inclusive workplace drives innovation and strengthens our ability to serve our people, clients and communities. Join us in fostering a culture where everyone feels valued, respected and empowered to achieve their full potential. Additionally, we provide reasonable accommodations to qualified individuals with disabilities, in accordance with applicable laws.

Education

Degrees/Field of Study required: Degrees/Field of Study preferred: Certifications (if blank, certifications not specified) Required Skills Optional Skills Accepting Feedback, Accepting Feedback, Active Listening, Behavioral Economics, Business Transformation, Communication, Customer Strategy, Customer Value Maximization, Customer Value Proposition (CVP), Emotional Regulation, Empathy, Inclusion, Intellectual Curiosity, Market Share Analysis, Market Trends, Optimism, Price/Performance Analysis, Price Verification, Pricing Model, Pricing Software, Pricing Strategy, Pricing Trends, Profitability Management, Profitable Growth, Profit and Loss Analysis {+ 8 more} Desired Languages (If blank, desired languages not specified) Travel Requirements Not Specified Available for Work Visa Sponsorship? No Government Clearance Required? No Job Posting End Date

Additional Information

Are you ready to make a difference? Want to unlock new value by applying your unique perspective and talents? You can grow exponentially at PwC. Here, you can uncover hidden talents, build lifelong relationships rooted in trust and empathy and turn challenges into opportunities for innovation. We’ll help you grow your skills through challenging, meaningful work so you can go further.