Address WHY JOINING CONSUMER HEALTHCARE ? At Sanofi Consumer Healthcare, we have one shared mission – we're building a healthier future by helping people, help themselves. We empower people to champion better self-care for themselves, their communities, and our planet, through our consumer-inspired, science-based products and solutions. In order to do so, we strive to act as a force for good by integrating sustainability along our business and employees’ mission and operate responsibly from both a social and environmental point of view. Everything we do is centered around people – our consumers, our customers, healthcare professionals, and our employees – across the world. We are on an exciting journey as we have created a fully standalone CHC Business Unit (separating the Business Unit from our Pharma company heritage, processes etc), to create an agile, consumer-centric and responsive organization to deliver our ambition: to become the best Fast Moving Consumer Health (FMCH) company In & For the world. Sanofi’s Consumer Healthcare company is a standalone company as a separate legal entity but remains part of the Sanofi organisation.
CONSUMER HEALTHCARE AT A GLANCE • Join the #3 globally in Consumer Healthcare • We operate through our key platforms: Allergy, Physical & Mental Wellness, Pain, Digestive Wellness and Cough, Cold & Flu. • We provide over the counter healthcare solutions in over 150 countries • We have 12 major CHC manufacturing sites globally. • Our people work in more than 40 countries around the world. • We have nearly 10 000 employees globally who work together to serve healthier, fuller lives.
WHAT IS UNIQUE ABOUT CONSUMER HEALTHCARE? The Standalone strategy is an exciting and unique time to be involved in shaping the future of CHC organisation as it will unlock the value of our business and allow : • The integration of our business end-to-end from R&D to production and commercial, all dedicated to CHC in order to deliver bigger innovation, reduced time to market and exceed consumer and customer expectations • Improve our agility and way to operate to overtake local players and market growth momentum • Compete at par with CHC players, with processes & tools designed for CHC, gaining autonomy from our Pharma legacy • The acceleration of our digital journey transformation in order to build the true digital and data edge vs competition ranging from data driven decisions making to accelerating e-commerce and developing digital health opportunities to better engage with our consumers. We are building loved brands that serve 1bn consumers worldwide, and that have the opportunity to positively change lives, support healthcare systems and impact on the communities and society that we serve. As part of the CHC team, you will have the opportunity to work in an environment where people can thrive, grow, enjoy and be at their best. Our aim is to create an inclusive and exciting workplace for FMCH talents where we value authenticity, passion, speed and strong sense of purpose to work together as one CHC team.
LOOKING FOR A CHALLENGE?
Within Consumer Healthcare, we have the ambition to Grow and Perform even stronger and faster, ahead of the Market. That’s why we are looking for talents that will help us shape the future of CHC with skills and behaviours specific to the FMCH market. People who: • Like agility and new ways of working • Value operational autonomy and speed decision-making • Are passionate about data and digital transformation • Are consumer-obsessed and want to make a difference • Have an entrepreneurial spirit.
Are you ready to chase the miracles of science to improve people’s health?
✏️ What you'll do
- Define, coordinate, and contribute to the preparation of new registration dossiers and response documents to Health Authority questions, within the Science organisation for EU products/projects (MRP/DCP).
- Lead / Contribute to the preparation of scientific advice (including briefing package preparation), oral explanations and pre-submission meetings for EU projects/products.
- Develop regulatory strategy and provide expertise within project/product teams for products under development and/or marketed regional products.
- Provide EU input for development of the the Global Regulatory Product Strategy and ensure timely execution of defined milestones for global development projects as per blue print.
- Be accountable for the maintenance of the existing European portfolio (MRP/DCP), managing the maintenance activities such as renewal, variations (excluding CMC), WS, benefit/risk assessments, referrals, discontinuation process, PRAC signals, PBRER/PSUSA/DSUR, shared packs, etc.
- Ensure compliance of regulatory activities for development and marketed EU regional products.
- Internal Database update (Veeva Vault) for MRP/DCP (for regional information).
- Manage Health Authority interactions with RMS for European procedures.
- Provide regulatory contribution to Risk Management Plans, Periodic Safety Update Reports, Addendum to Clinical and Nonclinical Overview, Core labelling documentation (e.g., Company Core Data Sheets and Core Safety Profiles), DHPC for Regulatory Purpose, etc. for regional and defined multi-regional products/projects.
- Provide Regulatory support to policy, external trade association collaboration, and risk management.
- Provide regulatory support for registration activities in countries outside the Region, whenever related with MRP/DCP procedures.
- Steer operational excellence coordination and governance within Europe to ensure adherence to internal deadlines and KPIs, e.g., monthly validation of events of worldwide CHC medicinal products’ portfolio in accordance with Article 23, 23a, 123(2) of Directive 2001/83/EC prior to reporting to EMA (European Medicines Agency).
- Follow regulatory changes, competitors’ status and assess potential impact on daily activities and project strategy.
What we offer
- Immersion in the CHC environment and opportunity to work with a great team with diverse and highly advanced skill sets.
- A real & concrete career path at Local, Regional or Global level with P&L management & People management role opportunities
- Empowerment to do the right thing for the business.
Key working relationships
GRA, Pharmacovigilance, Labelling, Global Medical, Evidence Generation, Science Organisation, Marketing and Innovation, Public Affairs, Legal, Industrial Affairs, Business Development, Country Regulatory Teams.
Your profile
Technical skills
- University scientific degree
- at least 5 years regulatory experience, preferably in the coordination of european procedures (MRP/DCP).
- Knowledge of regulations in self-care area
- very fluent in English
- Very good knowledge of Microsoft package
Soft skills
- Ability to build relations at all level of the organization
- Ability to influence internal and external stakeholders
- Results orientation
- Think Strategically
- Team collaboration
- Strong interpersonal/communication skills
- Ability to work in a matrix environment
- Business acumen and customer orientation
- High standards of integrity
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
