Carl Denny Email & Phone Number

Cleveland, Oh, Us

Cleveland, Oh, Us

Lead regulatory affairs organization to support regulatory activities for cell and gene therapy portfolio development.

Cambridge, Ma, Us

Chicago, Us

Oversee the global regulatory activities for premarket regulatory submissions and new product development for assigned products. Responsible for the development and execution of global regulatory strategies. Close collaboration with Regional RA to support country specific regulatory activities and work plans. Interface with regulatory agencies globally to achieve strategic product goals.

Tokyo, Jp

Regulatory Site Leader for Emerging Market Regulatory Affairs - Takeda Deerfield, Illinois Responsible for the development and execution of emerging market regulatory strategies to support product lifecycle, including product development and post-marketing activities in all non-US and EU countries. Primary focus on Emerging Markets including Asia, Latin America, Middle East and region Africa, as well as Russia, India, China and select Tier I countries (Australia, South Africa, etc.). Responsibility encompasses all therapeutic areas, biologics and small molecules.

Responsible for the regulatory activities associated with the development, registration and maintenance of sponsor products. Provide regulatory assessment of pre-approval and post-approval commercial projects, regulatory strategy and responsibility for submission execution. Primary regions of responsibility are the Americas (Latin America, North America, and Canada), with additional responsibility as needed for Asia Pacific and the Emerging Markets.

In cooperation with regulatory affiliates and commercial colleagues, develop and support regulatory strategies for product registration in Central and Eastern Europe (CEE) and Russia.Support registration activities for assigned products in CEE & Russia region.

Indianapolis, Indiana, Us

Chemistry, manufacturing and Control - small molecules and biologics

M.S., Chemistry

B.S., Chemistry