Regulatory Affairs Manager
hace 1 día
City of London
Founded in 2012 by world-renowned plastic and reconstructive surgeon Dr Yannis Alexandrides, 111SKIN is a global skincare brand that bridges the gap between scientific innovation, luxury and community. Beloved by A-listers, high-profile makeup artists, and skincare connoisseurs, 111SKIN is also highly regarded by some of the most reputable editors and industry bodies. Whom we are looking for: A proactive Regulatory Affairs Manager who combines scientific precision with strategic thinking. What you’ll do: You will lead 111SKIN’s global regulatory strategy across all markets, ensuring our innovative products meet compliance standards while supporting speed to market. This includes managing complex registration pathways across USA, EU, UK, APAC and mainland China. The role blends hands-on regulatory work, such as dossier preparation, safety and ingredient review, and claims validation together with strategy to future-proof the brand for evolving global regulations. What success looks like: You will ensure 111SKIN’s products are globally compliant, safely formulated, responsibly packaged, and efficiently registered - while leading initiatives that strengthen regulatory resilience and enable innovation. We evaluate each team member based on our three company values: entrepreneurial mindset, caring collaboration, and determination to succeed. Why you are a great fit: You are a meticulous, highly organised professional with a passion for innovation in science-driven skincare. You combine strong regulatory knowledge with commercial awareness and strategic foresight. You enjoy leading projects that turn complex and changing regulations into clear, actionable frameworks. You thrive in a fast-paced, high-growth environment and bring both precision and leadership to your work. Duties and responsibilities: • Lead global regulatory strategy across key markets including the UK, EU, USA, APAC and China (NMPA) for cosmetics, supplements, and OTC products., • Develop and implement a proactive regulatory landscape strategy, ensuring 111SKIN stays ahead of evolving cosmetic, supplement, and OTC regulations., • Lead regulatory change projects, driving through updates to meet new legislation, industry standards, or internal policy improvements., • Manage change control processes for raw materials, formulations, packaging components, and artwork updates in coordination with NPD and Operations., • Prepare and review Product Information Files (PIFs), • Oversee safety and regulatory documentation for supplements, including label review, claims substantiation, and ingredient checks, • Manage China Domestic Registration (NMPA) processes, including ingredient screening, documentation coordination, and testing oversight with local partners., • review and approve packaging, artwork, and claims to ensure compliance with cosmetic, supplement, and OTC labelling requirements., • Oversee Extended Producer Responsibility (EPR) and packaging compliance across global regions, ensuring accurate reporting and alignment with sustainability objectives., • Partner closely with NPD, marketing and operations teams to guide compliant innovation and support global launches across all categories., • Maintain and update internal regulatory databases, including ingredient restrictions, packaging data, and country-specific requirements., • Liaise with external consultants, laboratories, and distributors to support compliance and registration activities globally., • Monitor and interpret global regulatory changes, communicating key insights to internal stakeholders., • Support internal and external audits, regulatory inspections, and compliance training initiatives. Requirements: • 5+ years’ experience in regulatory affairs within cosmetics, ideally skincare., • Strong understanding of global cosmetic regulations, including EU, UK, US (MoCRA and OTC), and China (NMPA) frameworks., • Experience reviewing, checking, and approving cosmetic formulations to ensure regulatory compliance and alignment with safety standards., • Proven experience organising, reviewing, and maintaining Cosmetic Product Safety Reports (CPSRs) and supporting documentation for Product Information Files (PIFs)., • Experience managing OTC drug products (e.g., SPF, acne, or treatment products), including FDA monograph compliance and drug listing submissions., • Proven experience leading regulatory change initiatives and maintaining change control for formulations, raw materials, and packaging., • Experience managing Extended Producer Responsibility (EPR) and packaging compliance across international markets., • Demonstrated experience in claims review for global compliance., • Familiarity with adverse event reporting and consumer safety surveillance systems., • Excellent written and verbal communication skills with strong attention to detail and scientific accuracy., • Highly organised, with the ability to manage multiple projects and deadlines in a dynamic environment., • Familiarity with systems such as CPNP, SCPN, MoCRA, and the FDA Drug Listing Portal., • Degree in cosmetic science, chemistry, pharmacy, or a related life sciences field. Culture & Benefits: Everything we do at 111SKIN is to help people. From giving customers the confidence to go makeup-free, to giving back to the community and preserving the environment. It’s part of 111SKIN’s DNA. It’s who we are. As a member of our team, we hope you will help us champion our values of entrepreneurial mindset, caring collaboration, and determination to succeed. Some of the benefits include: • Flexible working arrangement (3 days in our Central London office), • 4pm Friday finish and summer hours during July & August with a 2pm Friday finish, • 3 extra days of paid holiday during the festive period, • Religious holiday swaps, • 3 free 111SKIN products per month, • 85% employee discount on additional 111SKIN products, • 1 complimentary 111CRYO/Heat session per week, • 50% discount on non-surgical treatments at 111 Harley Street, • Expenses towards eye tests, • Bike2work scheme, • 2 weeks of compassionate leave, • IVF support At 111SKIN, we believe that diversity drives innovation and inclusion fosters creativity. We are committed to building a diverse team and creating an inclusive environment where everyone can thrive. We encourage applications from individuals of all backgrounds, experiences, and perspectives.