Junior Regulatory Affairs Advisor
Il y a 5 heures
Arrondissement of BrusselsCapital, Brussels, Belgique
PwC
Temps plein
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h3Job Description Summary /h3pLine 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. /ph3Your impact /h3ulliHelping clients navigate global regulatory requirements and identify practical solutions to regulatory challenges; /liliSupporting clients in interpreting EMA, FDA and National Competent Authority requirements and guidance; /liliContributing to client regulatory strategies, submissions and Health Authority interactions; /liliSupporting assessments and improvements of Regulatory Affairs processes, operating models and systems, including regulatory information management (RIM) solutions; /liliHelping clients understand the impact of new and evolving regulatory requirements on their products and activities; /liliTurning regulatory and scientific information into clear, actionable insights and recommendations; /liliSupporting broader Life Sciences client engagements, including projects spanning market access, health and regulatory policy, commercialisation and patient engagement, alongside multidisciplinary PwC teams. /li /ulh3About you /h3ulli1–2 years of Regulatory Affairs experience within the pharmaceutical, biotechnology or broader life sciences industry; /liliPractical exposure to EU pharmaceutical regulation, EMA procedures and/or National Competent Authorities; /liliExposure to regulatory submissions, lifecycle management, regulatory intelligence or Health Authority interactions; /liliExposure to Regulatory Affairs processes, systems or RIM platforms (e.g. Veeva RIM or similar) is an advantage; /liliKnowledge of FDA and global regulatory processes is an advantage; /liliBachelor's or Master's degree in Pharmacy, Biomedical Sciences, Biology, Chemistry, Life Sciences or a related scientific discipline; /liliRegulatory Affairs training, professional development or certification from recognised organisations such as TOPRA, DIA or RAPS is a plus; /liliStrong analytical, organisational, communication and problem‑solving skills; /liliA curious, collaborative and client‑focused mindset, with an interest in developing expertise across Regulatory Affairs and the broader Life Sciences sector; /liliAbility to work effectively across multidisciplinary and international teams and manage multiple priorities; /liliFluent in English is required; /liliFrench, Dutch or other European languages are a plus. /li /ulh3Life at PwC Belgium /h3ulliFlexible work patterns: Achieve the perfect balance between office and home life with our flexible hybrid work arrangements and family‑friendly schemes. /liliLifelong learning: Grow with us Take advantage of our diverse training opportunities and exciting career pathways to explore new disciplines and expertise. /liliFlexible rewards: Tailor your benefits to suit your lifestyle with our customizable rewards plan. /liliSustainable mobility: Choose eco‑friendly mobility options, from our soon‑to‑be fully electrified fleet to public transport, shared cars, ebikes, and more. /liliInclusive culture: Thrive in a diverse, inclusive workplace that values and celebrates every individual's contributions. /liliWellbeing focus: Enjoy a positive environment with our comprehensive wellbeing programs, engaging sports communities, and confidential support for all your professional and personal challenges. /liliGlobal network: Expand your horizons with opportunities to work abroad and t
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. /ph3Your impact /h3ulliHelping clients navigate global regulatory requirements and identify practical solutions to regulatory challenges; /liliSupporting clients in interpreting EMA, FDA and National Competent Authority requirements and guidance; /liliContributing to client regulatory strategies, submissions and Health Authority interactions; /liliSupporting assessments and improvements of Regulatory Affairs processes, operating models and systems, including regulatory information management (RIM) solutions; /liliHelping clients understand the impact of new and evolving regulatory requirements on their products and activities; /liliTurning regulatory and scientific information into clear, actionable insights and recommendations; /liliSupporting broader Life Sciences client engagements, including projects spanning market access, health and regulatory policy, commercialisation and patient engagement, alongside multidisciplinary PwC teams. /li /ulh3About you /h3ulli1–2 years of Regulatory Affairs experience within the pharmaceutical, biotechnology or broader life sciences industry; /liliPractical exposure to EU pharmaceutical regulation, EMA procedures and/or National Competent Authorities; /liliExposure to regulatory submissions, lifecycle management, regulatory intelligence or Health Authority interactions; /liliExposure to Regulatory Affairs processes, systems or RIM platforms (e.g. Veeva RIM or similar) is an advantage; /liliKnowledge of FDA and global regulatory processes is an advantage; /liliBachelor's or Master's degree in Pharmacy, Biomedical Sciences, Biology, Chemistry, Life Sciences or a related scientific discipline; /liliRegulatory Affairs training, professional development or certification from recognised organisations such as TOPRA, DIA or RAPS is a plus; /liliStrong analytical, organisational, communication and problem‑solving skills; /liliA curious, collaborative and client‑focused mindset, with an interest in developing expertise across Regulatory Affairs and the broader Life Sciences sector; /liliAbility to work effectively across multidisciplinary and international teams and manage multiple priorities; /liliFluent in English is required; /liliFrench, Dutch or other European languages are a plus. /li /ulh3Life at PwC Belgium /h3ulliFlexible work patterns: Achieve the perfect balance between office and home life with our flexible hybrid work arrangements and family‑friendly schemes. /liliLifelong learning: Grow with us Take advantage of our diverse training opportunities and exciting career pathways to explore new disciplines and expertise. /liliFlexible rewards: Tailor your benefits to suit your lifestyle with our customizable rewards plan. /liliSustainable mobility: Choose eco‑friendly mobility options, from our soon‑to‑be fully electrified fleet to public transport, shared cars, ebikes, and more. /liliInclusive culture: Thrive in a diverse, inclusive workplace that values and celebrates every individual's contributions. /liliWellbeing focus: Enjoy a positive environment with our comprehensive wellbeing programs, engaging sports communities, and confidential support for all your professional and personal challenges. /liliGlobal network: Expand your horizons with opportunities to work abroad and t