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Senior
Manager Regulatory Affairs
Pennsylvania
regulatory affairs manager jobs
Responsible for licensing and license maintenance of US products.
Work with management and Project Team members to develop strategies and
advice for addressing the issues for developmental and marketed products.
Represent the company during interactions with regulatory agencies.
Prepares
records of regulatory agency interactions.
Prepare or manage the preparation and submission of regulatory
applications, reports and correspondence to regulatory agencies.
Schedule, coordinate, prepare, and review Investigational Maintain an
intimate knowledge of regulations, particularly for biologics, including
proposed and final rules; assure that awareness of these regulations
exists within the department.
Maintain an intimate knowledge of corporate policies and procedures as
they relate to developmental and marketed products.
Monitor current and proposed regulatory and legal issues through external
meetings, workshops, and the Internet.
BS,
BA in Life Science or advanced degrees.
Regulatory Experience: 5 or more years in pharma and/or biologics
regulatory affairs.
Good understanding of regulations, guidelines, and scientific principles.
Very strong management experience.
Must have exceptional organizational skills and knowledge of FDA
regulatory requirements and ICH guidance. Interpersonal, administrative,
written and verbal skills required. Requires a self-starter with the
ability to work on his/her own as well as define, coordinate and direct
assignments to project team members.
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