JOB - Regulatory Affairs Specialist,

[Ssihouston]

JOB TITLE	SENIOR REGULATORY AFFAIRS SPECIALIST
JOB ORDER NUMBER	ARTWTX07
DEPARTMENT	UNKNOWN 
REPORTS TO	MS. CYNTHIA MOLINA
JOB STATUS:	DIRECT, FULL-TIME HIRE OR CONTRACT TO PERMANENT. 
PREFERENCE WILL BE GIVEN TO CONTRACT-TO-PERMANENT CANDIDATES.

POSITION SUMMARY
This Senior Regulatory Affairs Specialist will be responsible for
coordinating and preparing NDA and IND regulatory submissions for
oncologic and infectious disease products.  Must be sufficiently
familiar with clinical, pharmacological and CMC areas to provide
regulatory guidance to members of the various operating groups.  This
scientist will be responsible for writing summary sections of the
submissions and coordinating answers to FDA questions.  Experience
with European marketing submissions would be helpful. Excellent
written and oral communications skills are required as are excellent
organizational and program management skills.  The successful
candidates will be a company regulatory representative in direct and
regular contact with the FDA.  This position requires a Bachelor's or
Master's Degree from an accredited, four-year university in
biosciences and at least three, preferably five years of relevant
regulatory affairs experience in a pharmaceutical company.

PRINCIPLE RESPONSIBILITIES

=B7 Prepare and submit regulatory documents to the FDA (IND and NDA). =B7
Read, understand, compile various regulatory reports from different
fields and write appropriate regulatory summaries for submission to
FDA. =B7 Interact with and facilitate communication between staff
members working in clinical, pharmacological and chemistry fields so
as to coordinate the coherent submission of regulatory reports and
summaries.

REQUIRED QUALIFICATIONS:

=B7 Bachelor's of Arts or Science Degree (or higher) from an accredited,
four-year university.  Advanced degree is acceptable and preferred
(MS). =B7 Minimum of 3 years of directly relevant work experience in a
regulatory affairs position in a pharmaceutical company.  Five years
experience is preferred. =B7 Excellent interpersonal skills, especially
as they relate to the interaction with staffers in diverse scientific
fields to include clinical, pharmacological and chemical disciplines. 
Also essential is the ability to effectively interact with physicians,
other clinicians and members of the FDA and other governmental
agencies. =B7 Computer literacy with PC systems using Microsoft Windows
3.1 and Windows `95 operating systems and extensive experience with PC
based report writing via Microsoft Word and spreadsheet analysis using
Microsoft Excel. =B7 Excellent verbal and particularly written
communication skills required.
 This includes a requirement for excellent English grammar and
 diction.
=B7 Ability to calmly handle stressful situations brought on by
submission deadlines and the pressures inherent in a rapidly growing
biotechnology company. =B7 Willingness to travel at least 10% of the
time.

PREFERRED QUALIFICATIONS:

=B7 Supervisory experience or capabilities
=B7 Project management skills
=B7 Experience with European regulatory submissions
=B7 Experience in an identical position with a major, domestic or
western European pharmaceutical company.

David W. Walters, Ph.D.
Senior Scientific Recruiter
ScienStaff, Inc.
7007 Gulf Freeway, Suite 239
Houston, Texas  77087
Phone:  713-640-1929
e-mail:  ssihouston at aol.com