Roseline Van de Winckel

Senior Consultant Life Sciences

Liège, Walloon Region, Belgium

About

Organized, Proactive, Rigorous and multi-faceted, Resolutely sociable and empathetic, I have a Scientific education with 20 years experience both in the cosmetics and in the pharmaceutical fields. - Proven ability to work efficiently in cross-functional teams - Sound problem solving, communication and counselling skills - Client oriented approach - Independent and motivated with effective planning, organizational and project management skills - Communicative person – exchanges, shares and passes on - Accountability and flexibility – Proactively manages the workload and ensures all tasks are being delivered in a timely manner and according to established norms or requirements

Experience

  • Regulatory Affairs Specialist at Haleon
    Jan 2024 - Present · 2 yrs 6 mos

  • Senior Consultant at pi Life Sciences
    Oct 2022 - Feb 2023 · 5 mos

  • Regulatory Affairs Specialist at BVI Medical
    Jul 2021 - Jul 2022 · 1 yr 1 mo

    BVI® is a global ophthalmic medical device manufacturer with a mission to deliver high quality solutions and innovation for advancing eye surgery and improving the vision of patients. BVI has undergone a transformation into one of the fastest growing diversified companies in ophthalmology. We continue to be a trusted and valued partner to our customers and their patients, in more than 115 countries worldwide.

  • Regulatory Affairs Specialist at PhysIOL s.a.
    Jun 2021 - Jul 2022 · 1 yr 2 mos

    Created in 1986, PhysIOL has evolved from the University of Liege, Belgium, and has specialized in the R&D and manufacture of intraocular implants for cataract surgery. Since 2019, PhysIOL is part of the renowned US group BVI Medical.

  • Regulatory Affairs at Sanofi
    May 2019 - Dec 2020 · 1 yr 8 mos

    - Post – marketing regulatory activities and life-cycle management of CHC portfolio - Changes to initial approval, new product indications, Labelling - Regulatory advice to marketing department for marketing campaigns, promotional and communication materials - Accurate and timely submission of registration dossiers for RX and OTC medicines in Belgium. - Follow-up and maintenance of existing registrations - Keep track of modifications to registrations and follow up on the legislation and regulations in Belgium and Luxembourg. - Review and submission of promotional material (PromoMat) - Follow up on innovations (possible launches), assess regulatory strategy and timelines