Manager, Regulatory Affairs-hybrid role
2 weeks ago
PRIMARY RESPONSIBILITY
Under the supervision of Senior Regulatory Affairs staff, the Manager, Regulatory Affairs is responsible for developing, implementing, and leading short- and long-term global regulatory strategies that support the success of products throughout their lifecycle. Serves as the primary liaison to regulatory agencies and leads submission activities to regulatory agencies. Identifies and assesses regulations and guidance documents provides interpretive guidance applicable implementation. This position will work within cross-company development project teams and will provide regulatory expertise into strategic regulatory plans.
Key Responsibilities
Qualifications & Experience
Required Bachelor’s Degree required; advanced degree preferred Experience in drug development process Minimum 3 years of Regulatory Affairs experience Must have experience filing regulatory dossiers (CTAs, INDs, IMPDs, IDEs) Solid working knowledge of relevant domestic and global regulations and guidance Desirable Experience in cell and gene therapy and/or oncology is strongly preferred Experience with BLAs/NDAs/MAAs preferred
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