Regulatory Affairs CMC Speciaist

Regulatory CMC ConsultantContract: 18 Months Location: Copenhagen, Denmark (Fully Remote) Industry: Vaccines / Global Public HealthWe are supporting a leading pharmaceutical organisation on a high-profile Tuberculosis (TB) vaccine development programme and are looking for an experienced Regulatory CMC Consultant to join the team on an 18-month contract basis.This is a fully remote opportunity, working closely with global CMC, Regulatory Affairs, Manufacturing, and Quality teams to support regulatory strategy and submissions across the vaccine lifecycle.Key ResponsibilitiesLead Regulatory CMC activities for a TB vaccine development programme.Prepare, review, and manage Module 3 documentation for global regulatory submissions.Support interactions with health authorities and answer regulatory queries.Collaborate with CMC development, manufacturing, analytical, and quality teams to ensure submission readiness.Drive regulatory strategy for chemistry, manufacturing, and controls throughout development and lifecycle management.Support variation filings, responses to questions, and regulatory maintenance activities.Required ExperienceStrong Regulatory CMC experience within the pharmaceutical or biotechnology industry.Proven background supporting vaccine, biologics, or complex biologic product submissions.Experience authoring and reviewing Module 3 documentation.Understanding of global regulatory requirements across major markets.Experience working on infectious disease, vaccine, or public health-focused programmes is highly desirable.Ability to work independently within a global, cross-functional environment