•PhD pharmacist with 29 years in product development / CMC regulatory covering NCE, OTC, dietary supplements and medical devices•Experience of biotech as well as large and mid size pharma. •20 years of leading cross-functional, global project teams•Expertise in early phase and late phase product development, across a variety of dosage forms, both sterile and non-sterile•Expertise in paediatric product development•Extensive knowledge of cGMP and regulatory requirements•Managed formulation and analytical scientists, regulatory associates, consultants, CROs and CMOs•Led projects across the whole product development cycle from candidate selection to life cycle management•Responsible for creation, execution and evaluation of budgetary and operational project plans•Responsible for a number of OTC product launches•Successfully led the registration of medicines via the MR procedure, acting as BOH point of contact•Written, compiled and approved modules 1-5 of registration dossiers in eCTD format (IND, NDA, MAA), including SmPC, PIL, label, and drug safety information•CMC expert for regulatory submissions and BOH meetings•Product development and CMC regulatory expert for due diligence activities•Responsible for the identification of innovative product and technology opportunities and their dissemination through the organisation•Responsible for providing product development and CMC regulatory support to CROs, CMOs and internal colleagues•Responsible for the selection of CROs and CMOs and set up of necessary agreements/contracts•Responsible for dissemination of SME knowledge through internal and external training•Undertaken scientific research and presentation at conferences•Responsible for ensuring that work practices are safe and compliant with company, regulatory body and cGMP standards•Member of site management team with departmental responsibility for legal contracts, due diligences, technology transfer, stability facility and oversight of CROs and CMOs