FEATURED OPPORTUNITY
Director of Regulatory Affairs - Oncology
Regulatory leader with
oncology expertise needed to step up into executive management!
Our client is seeking a
hands-on director who has the executive presence to defend your
regulatory strategies to the senior-most management, while managing
a robust and exciting oncology pipeline with products in multiple
phases. You will wear many hats as our client expects at least 2 new
products each year, and 1 BLA filing a year! Reporting to one of the
most respected and well-liked leaders in the organization, you will
have the support to execute your vision and the autonomy to exert
your influence and expertise.
Responsibilities include:
Lead innovative regulatory
strategy development for all phases of drug development for
biological investigational products
Represents Regulatory
Affairs and provide guidance to Research, Development, and
Clinical at Project Team meetings. Assuring the RA CMC lead is
informed and involved as needed.
Submits regulatory
information to FDA and worldwide regulatory agencies including,
but not limited to, INDs, BLAs, preclinical and clinical
protocols and amendments, and adverse experience reports.
Plan, coordinate, prepare
and execute meetings and teleconferences with regulatory
agencies.
Prepares, manages, and
coordinates clinical trial applications and clinical trial
labeling with worldwide Contract Research Organizations and
Consultants.
Monitors product related
corporate activities for regulatory compliance, including all
preclinical and clinical plans and practices.
Leads regulatory review
and regulatory strategy development for Due Diligence
activities.
Interact with Company
Partners and Consultants for various regulatory matters as
needed.
Must be action oriented,
have customer focus, comfort around higher management, ability
to motivate teams, manage vision and purpose, and have excellent
time management and organizing skills
If you have the spirit to ambitiously oversee a dynamic oncology
pipeline, and the confidence and acumen to influence executive
management, then contact
us and forward your resume now!
Contact:
Amanda DeSalvatore
Project Manager
Avant Executive Solutions, LLC
amandad@avantexec.com