Senior Regulatory CMC Consultant (Drug Substance/ ADC)

Senior Regulatory CMC Consultant (Drug Substance/ ADC) 6-Month Contract (Renewable - ongoing) Remote Global Regulatory Strategy Are you a seasoned Regulatory CMC professional with deep expertise in drug substance development and a proven track record supporting global marketing authorisation submissions? We are supporting an innovative global biopharmaceutical organisation seeking a Senior Regulatory CMC Consultant to provide strategic leadership for the regulatory drug substance activities associated with a high-profile development programme. This role will have a particular focus on Antibody Drug Conjugates (ADCs), making prior ADC experience desirable but not essential. The Opportunity As a senior member of the Regulatory CMC team, you will be responsible for defining and driving the global regulatory strategy for the drug substance component of the programme, working closely with cross-functional teams across Europe and the United States. This is a highly visible position requiring both technical expertise and strategic regulatory leadership as the organisation prepares for key global submissions. Key Responsibilities Lead the Regulatory CMC strategy for the drug substance element of a complex biologics programme, with a particular focus on ADC linker-payload development. Provide strategic guidance for upcoming global Marketing Authorisation Applications, including submissions to the FDA and EMA. Act as the Regulatory CMC subject matter expert for drug substance ..... full job details .....