FEATURED OPPORTUNITY
Regulatory Affairs Director – USA
This integral regulatory affairs leadership position involves
interactions with core and extended project team members, health
authorities, and business partners, as applicable.
Responsibilities:
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Represent Regulatory Affairs viewpoint and expertise on assigned
project teams;
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Lead, facilitate, and coordinate regulatory team meetings;
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Initiate and update regulatory strategic plans for assigned
projects;
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Manage the preparation of original INDs, CTAs, NDA/BLAs and
corresponding international registration packages; and
amendments/supplements to these applications and responses to
regulatory agency questions;
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Manage the preparation of health authority meeting packages and
minutes of the meetings;
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Review and approve protocols, reports, and documents used in
regulatory submissions;
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Ensure project team objectives and timelines are supported with
regulatory deliverables;
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Supervise and mentor associates and managers;
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Keep abreast of all pertinent laws, regulations and guidances as
they pertain to regulatory strategies and submissions.
Requirements:
5 + years of experience in progressively responsible roles in
Regulatory Affairs.
Bachelors/Masters/Doctoral degree, advanced degree preferred, in a
scientific discipline
Experience in drug development, CMC, preclinical, or clinical areas.
Working knowledge of regional health authority (e.g. FDA) regulatory
requirements is essential; global experience a plus. Demonstrated
experience, knowledge and/or skills in the following areas:
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Preparation of documents for health authority submissions.
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Capacity for developing and maintaining excellent working
relationships with internal and external partners.
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Ability to adapt to a changing global regulatory environment
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High level of professionalism and customer focus
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Excellent verbal and written skills.
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Excellent supervisory skills.
Compensation: Competitive
Contact:
Amanda DeSalvatore
Project Manager
Avant Executive Solutions, LLC
amandad@avantexec.com