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Director
Regulatory Affairs
(possible VP).
Title and compensation
commensurate with experience.
Directs the activities of the Regulatory Affairs department including Regulatory Project
Liaison, Regulatory Operations, Regulatory
Surveillance/Information,
maintenance of the corporate regulatory archive and IND/NDA submission activities.
Develops and manages capital and operating budgets for the Regulatory
Affairs Department. Interacts directly with government agencies, including FDA Review
Divisions, to facilitate Agency assessment of IND and NDA applications.
Organizes and manages meetings with senior FDA Review Division personnel to obtain
commitments and agreements enabling rapid and compliant development of drug programs.
Provides regulatory strategy input to senior management in cross-functional development
groups (e.g., Program Management, Clinical Operations, Pre-Clinical Development) to assist
in development of
realistic and efficient objectives, budgets and overall resource allocation. Devises
strategies for rapid and cost-effective product development of new product candidates.
Provides regulatory oversight to nonclinical and clinical development teams including
study design issues and timing, logistics and operational recommendations. Develops
regulatory
submission strategies in agreement with defined project development objectives. Monitors
the US and international regulatory environments, and provides
senior management with assessments of the impact of new and changing regulations on the
company's research and development programs. Provides regulatory input to the business
development group.
Ensure the quality and on time delivery of regulatory documentation (INDs, NDAs) upon
execution of Phase1 and 2 clinical trials in various therapeutic areas.
Directly impact the design of regulatory and clinical strategies and will serve as the
liaison and point of contact on FDA meetings and submissions on behalf of company clients.
Function as the medical monitor on clinical trials conducted by the company.
Requirements
* MD or PhD degree
* 10+ years experience in academia,
government, and/or industry
Required: Experience in a consulting role with
a book of pharma/biotech clients, extensive FDA experience (possibly a former FDA
executive, and
a track record of successfully pulling clients through the regulatory hurdles in the U.S.,
Europe, and Pacific Rim). * Candidates who have a consultancy practice, CRO background, or
are currently in a regulatory law firm are strongly considered. |
To express your interest in this
position,
visit our Applicants page
to fill out the short registration form
or
E-mail Harlan Staffing Consultants. |
