Junior Regulatory Affairs Advisor
Il y a 10 heures
Arrondissement of BrusselsCapital, Brussels, Belgique
PwC Belgium
Temps plein
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ph3Contribute to creating a better tomorrow /h3 pThe 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. /p h3Bring your talent. Learn new skills. Make a positive impact. /h3 pPwC 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. /p pWithin our Life Sciences practice, we are looking for an Associate Regulatory Affairs Advisor with initial pharmaceutical or life sciences industry experience. /p pYou 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. /p h3Your impact /h3 pAs an Associate Regulatory Affairs Advisor, you’ll make an impact by: /p ul liHelping clients navigate global regulatory requirements and identify practical solutions to regulatory challenges; /li liSupporting clients in interpreting EMA, FDA and National Competent Authority requirements and guidance; /li liContributing to client regulatory strategies, submissions and Health Authority interactions; /li liSupporting assessments and improvements of Regulatory Affairs processes, operating models and systems, including regulatory information management (RIM) solutions; /li liHelping clients understand the impact of new and evolving regulatory requirements on their products and activities; /li liTurning regulatory and scientific information into clear, actionable insights and recommendations; /li liSupporting broader Life Sciences client engagements, including projects spanning market access, health and regulatory policy, commercialisation and patient engagement, alongside multidisciplinary PwC teams. /li /ul h3About You /h3 ul li1–2 years of Regulatory Affairs experience within the pharmaceutical, biotechnology or broader life sciences industry; /li liPractical exposure to EU pharmaceutical regulation, EMA procedures and/or National Competent Authorities; /li liExposure to regulatory submissions, lifecycle management, regulatory intelligence or Health Authority interactions; /li liExposure to Regulatory Affairs processes, systems or RIM platforms (e.g. Veeva RIM or similar) is an advantage; /li liKnowledge of FDA and global regulatory processes is an advantage; /li liBachelor's or Master's degree in Pharmacy, Biomedical Sciences, Biology, Chemistry, Life Sciences or a related scientific discipline; /li liRegulatory Affairs training, professional development or certification from recognised organisations such as TOPRA, DIA or RAPS is a plus; /li liStrong analytical, organisational, communication and problem-solving skills; /li liA curious, collaborative and client-focused mindset, with an interest in developing expertise across Regulatory Affairs and the broader Life Sciences sector; /li liAbility to work effectively across multidisciplinary and international teams and manage multiple priorities; /li liFluent in English is required; French, Dutch or other European languages are a plus. /li /ul h3Life at PwC Belgium /h3 ul liFlexible work patterns: Achieve the perfect balance between office and home life with our flexible hybrid work arrangements and family-friendly schemes. /li liLifelong learning: Grow with us Take advantage of our diverse training opportunities and exciting career pathways to explore new disciplines and expertise. /li liFlexible rewards: Tailor your benefits to suit your lifestyle with our customizable rewards plan. /li liSustainable mobility: Choose eco-friendly mobility options, from our soon-to-be fully electrified fleet to public transport, shared cars, ebikes, and more. /li liInclusive culture: Thrive in a diverse, inclusive workplace that values and celebrates every individual’s contributions. /li liWellbeing focus: Enjoy a positive environment with our comprehensive wellbeing programs, engaging sports communities, and confidential support for all your professional and personal challenges. /li liGlobal network: Expand your horizons with opportunities to work abroad and tap into extensive industry expe