Associate Director/Director, Regulatory Affairs, Oncology

<body topmargin=0 leftmargin=0 marginheight=0 marginwidth=0> <table cellpadding=0 cellspacing=0 border=0><tr> <td valign="top" colspan=2 height=82 BGCOLOR="#9900CC" TEXT="#080000"> <div> <FONT SIZE="6" COLOR="#FFFFCC" FACE="Book Antiqua" ><B>The Artac Seel Company, Inc.</B></FONT><FONT SIZE="3" COLOR="#FFFF99" FACE="Book Antiqua" ><B> </B></FONT><FONT SIZE="3" COLOR="#FFFF80" FACE="Book Antiqua" ><B> </B></FONT><B>   </B><A HREF="index.htm" TARGET="_top" TITLE="TASC Home Page"><U><B>Home Page</B></U></A><B> </B></div> <div> <A HREF="id45.htm" TARGET="_top" TITLE="FULLTIME POSITIONS"><U>FULL-TIME POSITIONS</U></A>   |   <A HREF="id56.htm" TARGET="_top" TITLE="CONTRACT POSITIONS"><U>CONTRACT POSITIONS</U></A>   |   <A HREF="id48.htm" TARGET="_top" TITLE="RECRUITING"><U>RECRUITING</U></A>   |   <A HREF="id46.htm" TARGET="_top" TITLE="CONSULTING"><U>CONSULTING</U></A>   |   <A HREF="id49.htm" TARGET="_top" TITLE="ABOUT US"><U>ABOUT US</U></A></div> <div> </div> </td> </tr><tr> <td valign="top" width=340 BGCOLOR="#999980" TEXT="#080000"> <div> <B>Ellen Capito-Wightman, President</B></div> <div> <B>Corp. Phone  (860) 535-4419</B></div> <div> <B>FAX (860) 535-1842</B></div> <div> <A HREF="mailto:info@artacseel.com" TARGET="_top" TITLE="mailto:info@artacseel.com"><U><B>info@artacseel.com</B></U></A></div> <div> <A HREF="mailto: ellen@artacseel.com" TARGET="_top" TITLE="mailto: ellen@artacseel.com"><U><B>E-Mail to Ellen</B></U></A></div> <bR> <div> <B><U>FULL-TIME POSITIONS</U></B></div> <div> <A HREF="id108.htm" TARGET="_top" TITLE="Director, Compliance Regulatory Affairs"><U>Director, Compliance & Regulatory Affairs</U></A></div> <div> <A HREF="id107.htm" TARGET="_top" TITLE="Scientist II, DMPK "><U>Scientist II, DMPK </U></A></div> <div> <A HREF="id106.htm" TARGET="_top" TITLE="Exec. Dir., Early Clinical Development "><U>Exec. Dir., Early Clinical Development - Inflam. & Immunology</U></A></div> <div> <A HREF="id105.htm" TARGET="_top" TITLE="Global Medical Affairs Disease Leader (E"><U>Global Medical Affairs Disease Leader (Exec. 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Director/Director</B></div> <div> <B>Reg. Affairs, Oncology</B></div> <bR> <div> <B>Posted November 21, 2008</B></div> <bR> <bR> <div> <B><IMG SRC="0e396330.jpg" border=0 width="150" height="51" ALIGN="BOTTOM" HSPACE="0" VSPACE="0"></B></div> <bR> <div> <B>5-10 Years Experience</B></div> <bR> <bR> <div> <B>Summit</B></div> <div> <B>New Jersey</B></div> </NOBR></tD> <tD VALIGN=CENTER BGCOLOR=#FFFFFF WIDTH="386"><div> <B>JOB DESCRIPTION: </B></div> <div> <IMG BORDER="0" SRC="Symb075c00b700f033000000.png" HEIGHT="16" WIDTH="24" ALIGN="bottom" HSPACE="0" VSPACE="0">Develop Regulatory Strategies (US and Global) and implementation plans for identified projects in development and line extensions</div> <div> <IMG BORDER="0" SRC="Symb075c00b700f033000000.png" HEIGHT="16" WIDTH="24" ALIGN="bottom" HSPACE="0" VSPACE="0">Become knowledgeable with European Regulatory laws/guidances and provide strategic and operational advice to the regulatory group and the development teams -so that this position becomes the “ go-to “ position for this information.</div> <div> <IMG BORDER="0" SRC="Symb075c00b700f033000000.png" HEIGHT="16" WIDTH="24" ALIGN="bottom" HSPACE="0" VSPACE="0">Be the lead Regulatory person and provide interface for FDA and other regulatory authorities.on assigned projects</div> <div> <IMG BORDER="0" SRC="Symb075c00b700f033000000.png" HEIGHT="16" WIDTH="24" ALIGN="bottom" HSPACE="0" VSPACE="0">Working with the Submissions group, prepare and produce Regulatory Submissions for FDA and other RA's using internal & external resources.</div> <div> <IMG BORDER="0" SRC="Symb075c00b700f033000000.png" HEIGHT="16" WIDTH="24" ALIGN="bottom" HSPACE="0" VSPACE="0">Identify issues that will impact programs and provide strategies for dealing with them.</div> <div> <IMG BORDER="0" SRC="Symb075c00b700f033000000.png" HEIGHT="16" WIDTH="24" ALIGN="bottom" HSPACE="0" VSPACE="0">Provide advice to marketing group on labeling issues.</div> <div> <IMG BORDER="0" SRC="Symb075c00b700f033000000.png" HEIGHT="16" WIDTH="24" ALIGN="bottom" HSPACE="0" VSPACE="0">Act as regulatory representative on various cross-functional teams</div> <bR> <div> <B>JOB REQUIREMENTS:</B> </div> <div> <B><U>Skills/Knowledge Required</U></B><B>:</B></div> <bR> <div> <IMG BORDER="0" SRC="Wing0a7300a700f033000000.png" HEIGHT="16" WIDTH="24" ALIGN="bottom" HSPACE="0" VSPACE="0">Bachelors degree in scientific discipline; Advanced scientific degree preferred; Experience in Oncology Drug Development preferred.</div> <div> <IMG BORDER="0" SRC="Wing0a7300a700f033000000.png" HEIGHT="16" WIDTH="24" ALIGN="bottom" HSPACE="0" VSPACE="0">5-10 years pharmaceutical industry experience, 7+ for Director (to include  5-7  years in reg  affairs).  Global experience desirable.</div> <div> <IMG BORDER="0" SRC="Wing0a7300a700f033000000.png" HEIGHT="16" WIDTH="24" ALIGN="bottom" HSPACE="0" VSPACE="0">Thorough knowledge of the drug development process.</div> <div> <IMG BORDER="0" SRC="Wing0a7300a700f033000000.png" HEIGHT="16" WIDTH="24" ALIGN="bottom" HSPACE="0" VSPACE="0">Specific expert knowledge in one or more key areas-                                                             Oncology Drug Development/CMC/pharmtox/biopharmaceutics/clinical/labeling</div> <div> <IMG BORDER="0" SRC="Wing0a7300a700f033000000.png" HEIGHT="16" WIDTH="24" ALIGN="bottom" HSPACE="0" VSPACE="0">Inter-dependant partnering skills, team-orientated  and  ability to influence outcomes are necessary skills in the environment.</div> <div> <IMG BORDER="0" SRC="Wing0a7300a700f033000000.png" HEIGHT="16" WIDTH="24" ALIGN="bottom" HSPACE="0" VSPACE="0">Excellent organizational, communication  and time management skills needed to manage multiple ongoing projects simultaneously.</div> <div> <IMG BORDER="0" SRC="Wing0a7300a700f033000000.png" HEIGHT="16" WIDTH="24" ALIGN="bottom" HSPACE="0" VSPACE="0">Must be able to innovate, analyze and solve problems with minimal supervision and attention to detail</div> <div> Domestic and occasional International travel may be necessary</div> </tD> </tR> </TABLE></div> <div> <B><U>The Artac Seel Company</U></B></div> <div> --Effectively Delivering Talent in Pharmaceuticals & Biotech--</div> </td> </tr></table></body>