Join Alkermes' mission of making a difference in mental health and addiction treatment. Seeking a Director for CMC Regulatory Affairs to lead a team crafting strategies for innovative neuroscience programs. Must excel in Health Authority regulations,...
Lead global Regulatory Affairs CMC strategies for gene therapy products, ensuring compliance, successful submissions, and health authority approvals. Collaborate with internal teams, prepare submissions, and engage with regulatory authorities. Overse...
Hiring for CMC 2 Regulatory Affairs at Merck Animal Health. Manage CMC compliance, author CMC documentation, develop regulatory strategies, review quality documents, and ensure global product registration. 4-7 years of industry experience, science/en...
Seeking a passionate Director of Regulatory Affairs - CMC to join Agios Pharmaceuticals. Lead project teams in creating high-quality CMC submission documents, ensuring compliance with regulations. Requires 14 years of relevant experience, strong comm...
Seeking a Global Regulatory CMC Manager in Lawrenceville, NJ. Lead CMC regulatory strategy for biologics submissions, including IND/CTA, BLA/NDA, and MAA filings. Manage CMC change controls globally. Represent R&D Partners on cross-functional teams. ...
Lead the Regulatory Affairs CMC team, spearheading global strategies and submissions for Venatorx's development projects. Provide expert guidance for regulatory compliance, fostering cross-functional collaboration. Drive innovations, evaluate risks, ...
Join Ionis Pharmaceuticals in Carlsbad, CA, leading RNA-targeted therapy. Seeking a Director, CMC Regulatory Affairs responsible for global regulatory strategies, submissions, and approvals. Liaison with authorities, drive CMC leadership within Regul...
Lead the strategic direction of CMC Regulatory Affairs for Synthetic Products in Oncology. Direct global regulatory strategy and compliance to secure drug approval and supply continuity. Collaborate with cross-functional teams to achieve business goa...
Lead the regulatory-CMC strategy remotely for a global Bio-Pharmaceutical company, overseeing early to late-phase development and NDA/MAA preparations. Ideal for experienced leaders with strong regulatory CMC knowledge and global HA interaction skill...
Lead the CMC regulatory planning and execution for Venatorx's development assets. Advise global project teams on CMC strategies, prepare submission documents, resolve regulatory issues, and ensure compliance with guidelines. Drive effective partnersh...
