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HUTCHMED
Director/Senior Director, Regulatory Affairs
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Job Description
Director/Senior Director, Regulatory Affairs at
HUTCHMED
Director/Senior Director, Regulatory Affairs at
HUTCHMED
in Madison, New Jersey Posted in about 23 hours ago.
Type:
full-time
PRIMARY FUNCTION
The Director/Senior Director, Regulatory Affairs role will establish Regulatory Affairs function within
HUTCHMED
International. He or She will support the global product team in the development of sound global registration strategies for our pipeline which can lead to a successful approval of our product/s within US and EU. The ideal candidate will be utilizing therapeutic area regulatory expertise to provide high quality, timely and decisive regulatory guidance to facilitate global product team's decisions on development and/or lifecycle planning.
MAJOR RESPONSIBILITIES AND DUTIES
Responsible for preparation, approval and timely submission of regulatory filings, including but not limited to IND, (s)NDA, meeting briefing packets and other HA inquiries. Develop submission strategies and filing timelines in partnerships with global product team, functional heads, project leaders and external collaborators. Serve as the primary point of contact for
HUTCHMED
with US FDA and other health authorities as appropriate; and inform global product team and management of communications with health authorities as appropriate. Prepare the global product team members for all heath authority meetings, teleconferences, presentations by proactively identifying potential questions/answers, gain alignment on responses and organize rehearsals, as appropriate Serve as the meeting facilitator for all health authority meetings. Coordinate with global product team functional heads within HUTCHMED and CRO partners, as appropriate, to address any questions from health authorities in the US and Europe.
QUALIFICATIONS BS
degree in scientific or health sciences discipline (e.g., pharmacy, clinical pharmacology or public health or related scientific discipline) Advanced degree preferred, PhD, PharmD Minimum 10 years industry experience; 2 years management experience Successful track record of US and EU filings, INDs, NDAs, BLAs, sBLAs and product approvals Good understanding of regulatory policy, GCP and ICH guidelines Knowledge of drug development processes in US and EU and awareness of evolving regulatory reform initiatives Good leadership, organization & communication skills