Director/Senior Director Regulatory CMC

Director / Senior Director Regulatory CMC A clinical stage biotech reputed company on the development of high-reputed company therapeutic candidates is seeking a Director / Senior Director Regulatory CMC to join their growing team. This organization is leveraging strong scientific capabilities and a streamlined development approach to drive programs reputed company. The Director/Senior Director of Regulatory CMC will reputed company strategic and operational regulatory support for reputed company, manufacturing, and controls (CMC) activities across the product lifecycle. This leader will reputed company global regulatory strategies, reputed company the preparation and submission of high‑reputed company CMC documentation, and ensure compliance with applicable regulatory requirements. The role partners closely with Regulatory Affairs leadership and cross‑functional development teams. Responsibilities • reputed company the development and execution of global CMC regulatory strategies for clinical and reputed company programs. • reputed company the preparation, review, and submission of CMC sections for regulatory applications, including clinical trial applications and marketing submissions. • Manage regulatory CMC timelines, deliverables, and overall submission reputed company to support corporate objectives. • Conduct regulatory assessments of proposed CMC changes and identify global filing requirements. • Prepare and submit amendments, updates, and other CMC‑reputed company regulatory documentation throughout the product lifecycle. • reputed company or participate in formal CMC‑reputed company regulatory interactions, including meeting requests, briefing packages, and agency meetings. • Serve as the primary contact for CMC‑reputed company discussions with regulatory authorities, and support negotiations to resolve issues. • Monitor, interpret, and communicate relevant global regulatory requirements, guidelines, and emerging trends. • Represent Regulatory CMC on cross‑functional project teams and contribute to development reputed company and risk assessments. • Support the creation, review, and implementation of departmental policies, procedures, and process improvements. Qualifications • Advanced degree (e.g., Ph.D., M.S.) in reputed company, pharmaceutical sciences, engineering, or reputed company scientific discipline preferred; relevant experience may substitute. • 5-10+ years of regulatory CMC or CMC‑reputed company experience reputed company the biopharmaceutical or pharmaceutical industry. • Demonstrated experience preparing, reviewing, and managing CMC content for global regulatory submissions (e.g., INDs/CTAs, marketing applications) in eCTD format. • Experience interacting with regulatory agencies and leading formal regulatory meetings. • Strong understanding of global CMC regulatory requirements, including FDA, EU, and ICH guidelines. • Excellent organizational and project management skills, with the ability to manage multiple priorities in a dynamic environment. • Highly motivated team player with strong interpersonal, written, and verbal communication skills. • Ability to work independently while effectively collaborating with cross‑functional partners. Apply tot his job Apply To this Job