Regulatory Affairs Manager
New Jersey All, NJ
The Regulatory Affairs Manager (Consultant) will participate in the preparation of regulatory submissions and manage related requirements and timelines. The incumbent will interact closely with a range of internal and external partners including Regulatory Operations, Clinical Operation, Contract Research Organization (CRO), and Clinical Supply on a range of regulatory activities related to clinical studies.
Bachelor's degree in scientific discipline or related field required
Minimum of 5-7 years of experience in the industry with at least 3-5 years in Regulatory Affairs.
Experience working in a multicultural, multi-lingual environment.
Knowledge and Skills:
In-depth knowledge of the regulatory submissions process and related FDA regulations.
Strong organizational skills coupled with a sense of urgency; proven ability to manage processes to timeline.
Excellent interpersonal and cross-functional collaboration skills.
Strong attention to detail; a track record of error-free FDA submissions.
Competency in MS Office and Documentum
Willingness to travel up to 5%