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Associate
Director Regulatory Affairs
New
Jersey
Track
record of substantial accomplishment in Regulatory Affairs especially in
new Drug Approvals including OTC Switch Applications. Ability to exercise
sound judgment and independent action is essential.
Will develop Regulatory strategies, and action plans and will direct all
aspects of Regulatory Programs to effectively and efficiently bring new
product opportunities to market. The position also has responsibility to
ensure that marketed products are in compliance with applicable Government
Regulations.
Act as a primary Regulatory Advisor to project specific business teams and
ensure sound, timely, Regulatory counsel, guidance and services on a
proactive basis to assigned business clients on existing and new OTC
products.
Develop Regulatory strategies and provide leadership to business clients
in development of new products plans.
Ensure expeditious development of Regulatory submissions (e.g.
IND
, NDA, ANDA) for new
Rx to OTC switch products and other new OTC products/indications to gain
earliest feasible approvals for new products.
Act as official company representative to conduct liaison with FDA to
secure approvals of NDA's for new products.
Recruit, train, and develop direct reports, ensuring ability to lead all
Regulatory initiatives.
Advanced
Degree(s) (Ph.D., JD) preferred.
Minimum 10 years-preferably 15+ years Regulatory experience in IND/NDA
submissions including OTC switch and FDA Advisory Committee reviews.
5+ years in leadership/supervisory role.
Ability to make sound, well-reasoned, high quality decisions.
Entrepreneurial energy and enthusiasm to drive for results.
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