Manager, Regulatory Affairs

Location
Tarrytown, NY, United States
Posted
Oct 12, 2020
Ref
20752BR
Required Education
Masters Degree/MBA
Position Type
Full time
Regeneron Pharmaceuticals, Inc. is seeking a Manager, Regulatory Affairs for Tarrytown, NY location. Act as liaison between company and PMDA for assigned programs. Participate in multidisciplinary project teams to develop regulatory strategy for registration of new drugs in Japan, provide guidance on the content, format and timelines for regulatory submissions in Japan, including CTNs and J-NDAs. Author and/or review documents (non-clinical, clinical, manufacturing) for submissions in Japan and evaluate conformance with the Japanese regulatory requirements. Continually monitor newly published PMDA guidelines and international guidance documents in the context of new and ongoing development programs. Provide training on applicable Japanese requirements to scientific staff in Global Regulatory Affairs Department and other departments as needed.

Must possess a Master's degree or foreign equivalent in Chemistry, Biochemistry or related Scientific field and 2 years of experience in pharmaceutical industry. Must possess 2 years of experience working in Japan regulatory affairs in each of the following: CTN application submission & approval process in Japan; with J-NDA submission & approval process in Japan; PMDA official consultations for new drugs under development; and with direct communication with the MHLW/PMDA. Up to 10% international and domestic travel.

To apply, please mail resume to Mark Pass, Regeneron Pharmaceuticals, 777 Old Saw Mill River Rd, Tarrytown, NY 10591. Please reference requisition code 20752BR when applying. #LI-DNI, #GD-DNI, #IN-DNI