| Director of North American Regulatory
Affairs
Location: Northeast
Responsible for directing
and coordinating all North American regulatory activities on a day-to-day basis. Acting
under the supervision of the V. P., Clinical and Regulatory Affairs, will assist with the
development
and implementation of strategies for the earliest possible approvals of marketing
applications. Will provide expert analysis and evaluation of U.S. and Canadian
regulations. Will follow, evaluate the impact of, and analyze trends of U.S. and Canadian
governmental regulatory activities.
Specific duties will include
the supervision of Regulatory Affairs associates and specialists responsible for the
following activities:
Communication with
regulatory agencies, including:
Drafting, coordinating
review of, and editing of letters
Telephone conferences
Meetings
Coordination of regulatory
submissions,
including INDs and BLAs
Review of company documents
for regulatory compliance
Recording and maintaining
summaries of regulatory meetings and other important regulatory interactions
Filing annual and other
periodic reports with regulatory agencies
Training personnel on
regulatory issues
Developing regulatory
strategies and timelines for specific projects
Staying current in
regulatory knowledge and
regulatory agency policy
Skills and Knowledge: This
position requires knowledge of, and experience with pertinent current regulatory standards
and applicable U.S. and
Canadian regulations and policies. Excellent interpersonal and communications skills
combined with a scientific background. Interact effectively with members of company
project teams to ensure regulatory compliance in all assigned projects. Educational
Requirements: Post graduate degree required. Doctoral degree is preferred. Experience:
At least five years of experience in regulatory affairs
in pharmaceutical/biotechnology industry.
Supervisory experience required. Previous
experience in biopharmaceutical development
is preferred.
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