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 worki=
ng
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 regulator=
y
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 require=
d.
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
