Sep 28, 2023
Alkermes, Inc.
On Nov. 2, 2022, Alkermes plc announced its intention to explore separation of its oncology assets, including nemvaleukin alfa, IL-12 and IL-18. Alkermes plc intends to create a new, publicly-traded company to develop and commercialize such oncology assets. Referred to herein as "Mural Oncology." Alkermes, Inc., a subsidiary of Alkermes plc, is recruiting the position of Manager, Regulatory Affairs for Mural Oncology in advance of its establishment as a publicly-traded company on The Nasdaq Stock Market.
Oversees Chemistry, Manufacturing and Controls (CMC) Health Authority submissions (IND, IMPD, CTA) content for biologics development programs. Represents Regulatory Affairs and provides strategic input for CMC team activities supporting an emerging portfolio of biologics products. Collaborates across the business and with external partners to develop submissions content and strategy. Member of a Regulatory CMC department that supports a portfolio of small...
Professional Diversity Network
Waltham, MA, USA
Full-Time