REGULATORY AFFAIRS

#45-9249    Regulatory Affairs Manager
BS/BA Degree in Chemistry or related and five or more years experience in Electronic ANDA submissions, annual reports, ADE reports, labeling and supplements.

#73-9229    Regulatory Affairs Director
BS/BA Degree and eight or more years pharmaceutical industry experience with emphasis on clinical and non-clinical disciplines subject to FDA regulations.  Must have at least 5 years experience in management level positions, plus an extensive background in CMC, IND, NDA, and ANDA areas.  International experience will be a plus.   Aseptic manufacturing experience is preferred.   New position with expanding company. 

#75-9240    Director, Regulatory Affairs
BS/BA Degree and five years regulatory experience, preferably with a biopharmaceutical drug development company.  Responsibilities will include: Submission and approval of INDs, DMFs, BLAs, and supplemental applications and required regulatory reports, management of adverse drug events; investigations; product recalls; labeling; etc.  Experience with oncology, cardiovascular disease, orthopedics, or autoimmune diseases will be a plus but not required.   Small but well established, well managed company.

#70-9220    Manager, Regulatory Affairs
The person will be the regulatory representative for day to day operations at this facility. Responsibilities include development, implementation and distribution of all Quality System Documentation.  Requirements include a BS/BA Degree and 6 or more years pharmaceutical or medical device experience with at least 3 years of that experience being in regulatory affairs.   Excellent, fast growing company.

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HOW TO APPLY FOR OR RECEIVE ADDITIONAL
INFORMATION ABOUT ANY OF THESE POSITIONS:

 *Go to the following link to forward your resume to us (we will NOT send your resume to any
company or person without first contacting you for approval): Resume transmittal and/or Questionnaire
*or simply attach your resume to an email and forward to: myresume@slcollins.com
*or send an E mail to obtain more information about any of these positions: positions@slcollins.com