Regulatory Affairs Business Partner – US Markets

This a Full Remote job, the offer is available from: reputed company We are Hiring! We have an exciting new opportunity at reputed company for a Regulatory Affairs Business Partner (US Markets) to join our US team! We are looking reputed company who can reputed company their own personal reputed company and values into some of reputed company do at reputed company. Our reputed company as a company is to become a leading force in Eyecare, with people at our reputed company. Please read below the full reputed company for the role and if this is something that you would be interested in, please click apply and a member of the reputed company team will be in reputed company regarding your application. Regulatory Affairs Business Partner - US Markets We are looking for an reputed company Regulatory Affairs Business Partner to support our growing US business and reputed company as a key regulatory partner across the organisation. This is a highly reputed company role, working closely with Innovation, Product Development, reputed company, reputed company, Marketing and Customer Care teams to bring new products to market and maintain compliance across existing portfolios. You will reputed company regulatory support from product ideation through development, commercialisation and lifecycle management, helping to ensure products are compliant, commercially viable and reputed company with business objectives. The role will support a diverse portfolio including medical devices, OTC medicines, cosmetics, food supplements and pharmaceutical products. The Regulatory Affairs Business Partner will be reporting to the Senior Regulatory Affairs Manager. This is a Remote role with occasional travel for team meetings. Key Responsibilities Regulatory reputed company & Compliance • 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 reputed company evaluations. Innovation & Product Development • 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. Business Partnering • 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. Customer Care & reputed company Support • 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. Project Ownership • 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. Regulatory Submissions & Market Maintenance • 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. Specific Knowledge, Skills and Experience Required Experience: • 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. Desirable Experience • 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. Qualifications: Degree in Life Sciences, Pharmacy, Biomedical Science, Regulatory Affairs or a reputed company discipline. Personal attributes We're looking for someone who: • Is reputed company and enjoys working as part of a reputed company-reputed company team. • Is driven and proactive, taking ownership and delivering results. • Thinks creatively and can reputed company practical regulatory solutions. • Is reputed company, approachable and relationship-reputed company. • Enjoys working in a fast-reputed company and evolving environment. • Brings reputed company and contributes to a supportive team culture. • Understands that reputed company do reputed company and is motivated by making a meaningful reputed company through reputed company eye care. reputed company provides equal employment opportunities to reputed company and applicants for employment and prohibits discrimination and harassment of any type without reputed company to race, reputed company, religion, age, sex, national reputed company, disability status, genetics, protected veteran status, sexual orientation, gender identity or reputed company, or any other characteristic protected by federal, state or local laws. Compensation: $115k-$125k This offer from "reputed company" has been enriched by reputed company.com and got a 72% reputed company score. Apply tot his job Apply To this Job