Director/Sr. Director, Regulatory Affairs

<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> <bR> <div> <B>FULL-TIME POSITIONS</B></div> <div> <B><U>FULL-TIME POSITIONS</U></B></div> <bR> <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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Provides strategic and operational advice to the development and commercialization teams, serving as the primary global point person for assigned projects.</div> <div>  4.  Evaluates emerging regulations and changing regulatory landscape for impact and provides strategic advice for assigned projects. </div> <div> 5.  Provides leadership to the larger regulatory team that supports assigned projects and manages assigned regulatory staff. </div> <div> 6.  Is the lead Regulatory person and provides primary interface for FDA for assigned projects. </div> <div> 7.  Works with the regulatory product managers (submissions) and regulatory operations group, for the preparation, production and submission of health authority documents using internal & external resources. Works with regional staff outside US for ROW health authority submissions.</div> <div>  8.  Identifies issues or is assigned projects that will impact Celgene, regulatory affairs or projects and provides strategies for dealing with them. </div> <div> 9.  Provides advice to marketing group on labeling and promotional issues. </div> <div> 10. Acts as key regulatory representative on various cross-functional teams as assigned. </div> <bR> <bR> <div> <B>JOB REQUIREMENTS:</B> </div> <div> <IMG BORDER="0" SRC="Symb075c00b700f033000000.png" HEIGHT="16" WIDTH="24" ALIGN="bottom" HSPACE="0" VSPACE="0">Advanced degree in scientific discipline; PhD or PharmD preferred. 8-12 years pharmaceutical industry experience (to include 6-8 years in reg affairs). </div> <div> <IMG BORDER="0" SRC="Symb075c00b700f033000000.png" HEIGHT="16" WIDTH="24" ALIGN="bottom" HSPACE="0" VSPACE="0">Global experience very desirable. US experience necessary. EU/ other regional experience good to have. </div> <div> <IMG BORDER="0" SRC="Symb075c00b700f033000000.png" HEIGHT="16" WIDTH="24" ALIGN="bottom" HSPACE="0" VSPACE="0">Thorough knowledge of the drug research, development, and commercialization process. </div> <div> <IMG BORDER="0" SRC="Symb075c00b700f033000000.png" HEIGHT="16" WIDTH="24" ALIGN="bottom" HSPACE="0" VSPACE="0">Demonstrated specific expert in one or more key areas - Oncology/CMC/pharmtox/biopharmaceutics/clinical. Inter-dependant partnering skills, team-orientated and ability to influence outcomes are necessary skills in the environment. </div> <div> <IMG BORDER="0" SRC="Symb075c00b700f033000000.png" HEIGHT="16" WIDTH="24" ALIGN="bottom" HSPACE="0" VSPACE="0">A sensitivity and experience with non-domestic organizations / environment is necessary. </div> <div> <IMG BORDER="0" SRC="Symb075c00b700f033000000.png" HEIGHT="16" WIDTH="24" ALIGN="bottom" HSPACE="0" VSPACE="0">Excellent organizational, communication and time management skills are needed to manage multiple ongoing projects simultaneously. </div> <div> <IMG BORDER="0" SRC="Symb075c00b700f033000000.png" HEIGHT="16" WIDTH="24" ALIGN="bottom" HSPACE="0" VSPACE="0">Must be able to innovate, analyze and solve problems with minimal supervision and with good attention to detail.</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>