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Director, Regulatory Systems

Position supports the Regulatory Affairs
functions and has cross-functional interface
with all strategic business units within the
Division. Will cross all product lines and are
identified as such to achieve operational
efficiency and process consistency within
the regulatory affairs function as a whole, as
opposed to product-specific regulatory
resources. Interfaces with other Business
Depts. relevant to Regulatory Affairs:
Documentation, Labeling & Advertising,
Information Management, and Publishing.
Will keep current on all policies and trends,
domestic and international, impacting
regulatory affairs. Oversight of dept.
database maintenance and record keeping
with a focus on systems, compliance and
interaction with other groups. Contact Jim
at Harlan Staffing Consultants for additional
details.

Requirements: BS or MS Biological sciences, Pharmacy, or Medical Discipline relevant to
Regulatory Affairs. 5 years experience in pharmaceutical or biotechnology Regulatory
Affairs. Ability to think strategically, manage
and mentor, provide clear direction, and
communicate effectively.