Insmed Regulatory Cmc Leadership Position Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees, and everything we do is motivated by a patients-first mentality. We are dedicated to growing our team with talented individuals from around the world who are willing to challenge the status quo, solve problems, and work collaboratively with a sense of urgency and compassion. Guided by our core values of collaboration, accountability, passion, respect, and integrity, we aim to foster an inclusive, diverse, and flexible work environment, where our employees are recognized for leaning in and rolling up their sleeves. If you share our vision and want to work with the most dedicated people in the biopharma industry, come to Insmed to accelerate your career. Overview This position is a key role that will provide regulatory CMC (RA CMC) leadership and strategy to achieve regulatory approvals in various countries. As a strategic function, RA CMC is required to collaborate closely with multiple functions within Insmed and with external CROs/CMOs. A successful candidate will provide knowledge, understanding, interpretation, and utilization of regulatory guidance and regulations from various health authorities, as well as industry and government agency best practices and trends. Responsibilities Plan, implement, and manage regulatory submissions for compounds in various phases of clinical development, marketing applications, and post-approval lifecycle activities by working with various teams. Provide regulatory strategies and identify the gaps and challenges of CMC development to ensure the approvability of the drug products worldwide with the flexibility for post-approval maintenance and lifecycle management of the marketed products. Develop plans for the preparation of CMC meetings with the regulatory agencies, and draft and review regulatory documents for agency meetings. Provide interpretation of applicable FDA/EMA/ICH/WHO global regulations to ensure CMC compliance within regulatory filings. Keep abreast of all pertinent regulations and guidance documents for pre- and post-approval submissions. As needed, communicate regulatory CMC requirements to team members and advise of implications of the regulatory CMC strategies to CMC development plan and activities. Contribute to scientific discussions and collaborations with scientists to resolve technical and regulatory issues in drug substance synthesis, management of impurities and degradation products, formulation, manufacturing process, and device combination product development at various development stages and product lifecycle management. Stay current with regulatory guidelines and industry standard methodologies to ensure the company's RA CMC activities are aligned with regulatory expectations. Lead and mentor a team of CMC professionals, encouraging a collaborative and high-performance culture. Requirements: * Advanced degree (Ph.D. preferred) in a relevant scientific field (e.g., Chemistry, Chemical Engineering etc.). * 12+ years of experience in pharmaceutical development and regulatory CMC within multinational pharmaceutical and biopharmaceutical companies, and 8+ years in a leadership position. * Deep understanding of US, EU, and Japan regulations for drugs/biologics with the ability to identify the differences in regulations across the regions. Proven track record of close collaboration with Regulatory Agencies as the lead in agency interactions and product development meetings. * Understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market lifecycle support. * Extensive understanding of relevant FDA, EU, ICH, PMDA guidelines, initiatives and regulations governing CMC dr