What the job looks like: Plan, prepare, revise and maintain the regulatory CMC documentation for the assigned products; Proactively develop, in cooperation with internal and external stakeholders, the global CMC strategies for the registration and maintenance of active substances and finished products; Provide advice to Grünenthal manufacturing sites, suppliers and customers/partners regarding CMC regulatory requirements considering national and international regulatory standards; Provide CMC assessment and strategic input for proposed product changes, identifying risks, proposing mitigations as well as highlighting opportunities to maximize chances of success for regulatory approvals; Partner closely with Quality, Regulatory Affairs, Supply Chain, Commercial, and external manufacturing partners to align on product and process changes. What you'll bring to the table: Bachelor’s, Master’s, or PhD in Pharmaceutical Sciences, Chemistry, or related scientific degree; + 5 years experience in the pharmaceutical industry, with at least 2 years in a CMC role; Strong background in CMC lifecycle management and post-approval change implementation; Deep understanding of small molecule manufacturing, control strategies, and regulatory compliance; Strong knowledge of global CMC regulatory requirements (ICH guidelines, GMP regulations and regulatory frameworks worldwide); Excellent organizational, management, and skills; Proactive decision-maker with the ability to balance risk, compliance, and business needs; Proven ability manage complex product portfolios; Capability to manage multiple tasks and prioritize in a regulated environment; Very good written and verbal communication skills in English; Good knowledge in verbal and written Spanish; Proficiency in Excel, Word, and digital documentation tools. #J-18808-Ljbffr