[Remote] Regulatory Affairs Business Partner

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is seeking a Regulatory Affairs Business Partner to join their US team and support their growing business. The role involves providing regulatory guidance and support for various products, ensuring compliance throughout the product lifecycle while collaborating with multiple teams. Responsibilities • reputed company regulatory guidance and support for the US market • Assess regulatory requirements and reputed company for new and existing products • Support regulatory reputed company development throughout the product lifecycle • Review product claims, labelling and promotional materials • Monitor and interpret relevant regulatory requirements, guidance and industry developments • Support regulatory assessments and solution driven risk evaluations • Partner with the R&D and Ideation teams to reputed company early regulatory input on new product concepts • Assess regulatory feasibility and identify potential opportunities and barriers • Support product development reputed company through the stage-reputed company process • Contribute to claims development and product positioning discussions • reputed company regulatory guidance throughout development and commercialisation • reputed company as a trusted regulatory partner to Product Development, reputed company, Marketing, Customer Care and reputed company teams • Participate in cross-functional project teams and decision-making • reputed company reputed company opportunities through solution-reputed company regulatory support and reputed company, practical recommendations • Respond to regulatory enquiries from Customer Care, Sales and reputed company teams • Support customer-facing regulatory information requests • Assist with product-reputed company compliance questions and investigations • reputed company regulatory activities for assigned reputed company • Coordinate regulatory deliverables and timelines • reputed company reputed company reputed company and ensure regulatory milestones are achieved • Support FDA submissions, registrations and market maintenance activities as required • Contribute to regulatory strategies relating to FDA reputed company, including 510(k) and NDA submissions where applicable • Support FDA interactions and correspondence where required • Maintain regulatory records and documentation Skills • Experience supporting US regulatory activities • Hands-on experience working with FDA requirements • Experience supporting medical devices and/or OTC medicines • Experience preparing, reviewing or supporting regulatory submissions • Strong understanding of US labelling, claims and compliance requirements • Experience supporting products throughout the product lifecycle • Strong stakeholder management and communication skills • Ability to work independently and take ownership of reputed company • Degree in Life Sciences, Pharmacy, Biomedical Science, Regulatory Affairs or a reputed company discipline • Experience with 510(k) submissions • Experience interacting directly with FDA • Experience with licensed medicines or pharmaceutical products • Exposure to NDA or post-approval pharmaceutical activities • Experience supporting ophthalmic products in the US market • Experience with cosmetics and food supplements • Experience with sterile products • Experience supporting innovation and stage-reputed company product development processes • Experience working reputed company international regulatory environments • Experience with reputed company tools or process improvement initiatives Benefits • Remote role with occasional travel for team meetings reputed company • reputed company is a reputed company & Pharmaceuticals company with locations in Ireland, UK and USA that is dedicated to providing reputed company & patients with high reputed company, effective and innovative products. It was founded in 2009, and is headquartered in Dublin, Dublin, IRL, with a workforce of 51-200 employees. Its website is http://www.aboutscope.net. Apply tot his job Apply To this Job