Job title: Regulatory Affairs Consultant, CMC Reporting to: Senior Manager, CMC Functional group: EMEA Regulatory Affairs (R&D) Location : High Wycombe, United Kingdom – Hybrid (2/3 days per week in the office) Rate: £75- £85 per hour (PAYE/Umbrella) Cpl Life Sciences are collaborating with a leading consumer health business who are looking for a Regulatory CMC Consultant on a 6-month basis. Responsible for the development of CMC/technical regulatory strategies across the EMEA region providing regulatory input and technical guidance on regional regulatory requirements to product development teams within the Self Care franchise. Leads a Regulatory Affairs team ensuring the success of new product registrations, line extensions and new indications and claims with supportive technical justification/documentation in alignment with the business plan. Create an environment of operational excellence through regulatory expertise by managing direct reports and collaborating with cross-functional teams to successfully achieve regulatory objectives. Manages the global &/or regional regulatory deliverables for drugs, dietary supplements & medical devices as relevant, within their brand area & geographic responsibility. Develops strong partnerships with Regulatory Affairs Franchise, R&D, Marketing, Supply Chain and local business representatives. Represents the Regulatory Affairs CMC function as appropriate in Self Care Franchise, functional and business Leadership teams The Roles & Responsibilities include: Provides strategic regulatory input and technical guidance on regional regulatory requirements to product development teams Supports the business initiatives, by strengthening propositions, influence and acts as strategic advisor on brand/need state portfolio forums. Participates in cross-functional project teams to define development program requirements and risks Prepares and submits regulatory submissions according to applicable regulatory requirements and guidelines in EMEA. Regulatory Compliance Maintains awareness of current regulations and anticipate implications and opportunities because of changes to the relevant regulatory environments. Communicates changes to appropriate management and cross functional experts as appropriate Ensure that all products comply with local regulatory and quality system requirements. Ensures quality and compliance in all actions. Participate in the development and implementation of, and maintains compliance with, all applicable Processes, SOPs and working instructions Ensures that the enterprise Regulatory systems are accurate and fully maintained Ensure any compliance issues are reviewed and escalated and relevant corrective/preventative actions are implemented locally Identifies and/or implements regional process improvement opportunities and ensures implementation of relevant global or regional regulatory initiatives Team Management: Evaluates deliverables of self/direct reports against set timelines, acting where necessary to minimize delays and anticipate difficulties/risks. Specific requirements Partners with the business to deliver regulatory outcomes to enable committed business plans within area of responsibility. Job Requirements Relevant Bachelors Degree or higher Expertise across a broad spectrum of Regulatory classifications including Drugs, Dietary Supplement and/or Medical Devices, mainly pharmaceutical CMC regulatory affairs Knowledge of regulatory frameworks and external environments in the EU and wider EMEA, and the ability to apply these to regulatory solutions throughout the product lifecycle. Solid understanding of regulatory CMC in the markets of relevance Strong project management skills. Proficiency in English For more information, please reach out to me at lucy.kirkaldy@cpl.com