Bianca-Valentina Iuga
Regulatory Affairs Officer Eu @Ethypharm
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WORK HISTORY
Regulatory Affairs Officer Eu @Ethypharm
Romford, GB
Expedite new EU registrations according to CTD requirements (Modules 1 to 5) and post approval changes- Marketing Authorisation applications (MRP, DCP, Centralised or National)- Variations and renewal requests for existing authorisations- Answers to questions and post registration / approval submissions- Meeting packages for scientific advice and protocol assistance- Preparation of product labelling texts and leaflets- Liaise with manufacturing, commercial, medical affairs and pharmaceutical development as well as external regulatory contacts (including regulatory agencies) to ensure all regulatory requirements for these submissions are met- Actively manage regulatory procedures for the review and approval of these submissions- Provide high quality regulatory advice on most efficient strategy for preparation, submission and approval of these submissions- Provide forward plans for the preparation, submission and approval of these submissions including timelines for implementation and launch to manage organisational expectations and budgetary requirements (including correct fee payment to the authorities)- Prepare and submit responses to questions from Regulatory Authorities- Collect, review, organise, assemble and check reports and summaries- Provide regulatory advice on change control requests and requests for information- Monitor and advise on the impact of the Sunset Clause- Co-ordinate and submit PSURs as required- Monitor product safety information, prepare and maintain product labelling for appropriate markets in cooperation with national country specific requirements and commercial approval- Review and approve artworks for use in submissions and in production- Anticipate and resolve complex regulatory issues independently- Actively participate as primary regulatory resource in cross-functional project teams- Publish regulatory submissions in eCTD format
EDUCATION
Universitatea de Medicină și Farmacie „Carol Davila” din București
Bachelor's and Masters Degree
UCL
Master of Science - MS, Pharmaceutics
ABOUT BIANCA-VALENTINA IUGA
I\'m a highly organized pharmacist with a background in Regulatory Affairs, Quality Assurance, and extensive volunteer work with NGOs. My experience spans the pharmaceutical sector, covering both Medicines and Food Supplements. During the COVID-19 pandemic, I actively supported the pharmaceutical sector, leveraging my expertise to navigate international regulations effectively. Driven by a passion for innovation, I\'m not just a pharmacist but also an entrepreneur. With a recently completed MSc in Pharmaceutics from UCL, I continue to expand my knowledge base, merging my expertise with creative entrepreneurship. My entrepreneurial spirit led me to venture into the cosmetics industry, where I blend my regulatory insights with innovative product development. Known for my decisive and goal-oriented approach, I thrive in fast-paced environments. My adaptability, combined with strong communication and interpersonal skills, allows me to maintain positive relationships and deliver exceptional results. With a deep understanding of diverse cultural practices, I bring extensive international experience to the table, enhancing my strengths in customer service and global collaboration. Let\'s connect and explore the possibilities together.
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