Director, Regulatory CMC

<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: ellen@artacseel.com" TARGET="_top" TITLE="mailto: ellen@artacseel.com"><U><B>E-Mail to Ellen</B></U></A></div> <div> <B><U>FULL-TIME POSITIONS</U></B></div> <div> <A HREF="id105.htm" TARGET="_top" TITLE="Global Medical Affairs Disease Leader (E"><U>Global Medical Affairs Disease Leader (Exec. Dir)</U></A></div> <div> <A HREF="id103.htm" TARGET="_top" TITLE="Exec. Dir., Clinical Research Physician,"><U>Exec. Dir., Clinical Research Physician, Leukemia</U></A></div> <div> <A HREF="id104.htm" TARGET="_top" TITLE="Global Exec. Dir/VP Phase 1 Leader"><U>Global Exec. 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Writing"><U>Senior Mgr., Med. & Sci. Writing</U></A></div> <div> <A HREF="id66.htm" TARGET="_top" TITLE="Senior Clinical Research Scientist"><U>Senior Clinical Research Scientist</U></A></div> <div> <A HREF="id67.htm" TARGET="_top" TITLE="Clinical Research Manager"><U>Clinical Research Manager</U></A></div> <div> <A HREF="id62.htm" TARGET="_top" TITLE="Clinical Trial ManagerOncology"><U>Clinical Trial Manager-Oncology</U></A></div> <div> <A HREF="id50.htm" TARGET="_top" TITLE="Clinical Research CRA"><U>Clinical Research CRA</U></A></div> <div> <A HREF="id51.htm" TARGET="_top" TITLE="Senior Director Oncology"><U>Senior Director - Oncology</U></A></div> <div> <A HREF="id54.htm" TARGET="_top" TITLE="Data Manager II"><U>Data Manager II</U></A></div> <bR> </td> <td valign="top" height=398 BGCOLOR="#FFFFCC" TEXT="#080000"> <div> <B><U>Director, Regulatory CMC</U></B></div> <div> <TABLE BORDER="6" CELLPADDING="7" CELLSPACING="7" WIDTH="677" BORDERCOLORLIGHT="#660099" BORDERCOLORDARK="#660099" FRAME="BOX" RULES="ALL" HSPACE="0" VSPACE="0" > <tR> <tD VALIGN=TOP BGCOLOR=#FFFFFF HEIGHT= 810 ><NOBR><bR> <div> <B>Director</B></div> <div> <B>Regulatory CMC</B></div> <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>8-10  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">Responsible for the development of the CMC regulatory strategy for submissions.  These submissions include IND/CTA/BLA, NDA, CTD and MAA regulatory filings.</div> <div> <IMG BORDER="0" SRC="Symb075c00b700f033000000.png" HEIGHT="16" WIDTH="24" ALIGN="bottom" HSPACE="0" VSPACE="0">Coordinate the preparation and review CMC submission documents, registration dossiers, and responses to health authorities with other relevant line functions.</div> <div> <IMG BORDER="0" SRC="Symb075c00b700f033000000.png" HEIGHT="16" WIDTH="24" ALIGN="bottom" HSPACE="0" VSPACE="0">Responsible for the regulatory evaluation of CMC change controls.</div> <div> <IMG BORDER="0" SRC="Symb075c00b700f033000000.png" HEIGHT="16" WIDTH="24" ALIGN="bottom" HSPACE="0" VSPACE="0">Responsible for the management of CMC activities related to specific developmental or commercial compounds.</div> <div> <IMG BORDER="0" SRC="Symb075c00b700f033000000.png" HEIGHT="16" WIDTH="24" ALIGN="bottom" HSPACE="0" VSPACE="0">Represent Regulatory CMC on CMC development/commercial and Regulatory Affairs teams.  In addition</div> <div> <IMG BORDER="0" SRC="Symb075c00b700f033000000.png" HEIGHT="16" WIDTH="24" ALIGN="bottom" HSPACE="0" VSPACE="0">Take on leadership role in the CMC development/commercial teams.</div> <div> <IMG BORDER="0" SRC="Symb075c00b700f033000000.png" HEIGHT="16" WIDTH="24" ALIGN="bottom" HSPACE="0" VSPACE="0">Interact with regulatory agencies and represent CMC at regulatory agency meetings.</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">Must have experience with CMC regulatory documents (NDA, MAA, CTD, BLA, supplements, responses and IND/CTAs)</div> <div> <IMG BORDER="0" SRC="Wing0a7300a700f033000000.png" HEIGHT="16" WIDTH="24" ALIGN="bottom" HSPACE="0" VSPACE="0">Experience in the development of CMC regulatory strategy</div> <div> <IMG BORDER="0" SRC="Wing0a7300a700f033000000.png" HEIGHT="16" WIDTH="24" ALIGN="bottom" HSPACE="0" VSPACE="0">Knowledge of FDA, EMEA and ICH guidelines.</div> <div> <IMG BORDER="0" SRC="Wing0a7300a700f033000000.png" HEIGHT="16" WIDTH="24" ALIGN="bottom" HSPACE="0" VSPACE="0">Knowledge of rest of world post approval guidelines</div> <div> <IMG BORDER="0" SRC="Wing0a7300a700f033000000.png" HEIGHT="16" WIDTH="24" ALIGN="bottom" HSPACE="0" VSPACE="0">Have a solution-oriented approach to problem solving</div> <div> <IMG BORDER="0" SRC="Wing0a7300a700f033000000.png" HEIGHT="16" WIDTH="24" ALIGN="bottom" HSPACE="0" VSPACE="0">Expertise in either the drug development process or post approval activities</div> <div> <IMG BORDER="0" SRC="Wing0a7300a700f033000000.png" HEIGHT="16" WIDTH="24" ALIGN="bottom" HSPACE="0" VSPACE="0">Ability to work on complex projects and within cross-functional teams</div> <div> <IMG BORDER="0" SRC="Wing0a7300a700f033000000.png" HEIGHT="16" WIDTH="24" ALIGN="bottom" HSPACE="0" VSPACE="0">Prior supervisor or project management experience</div> <div> <IMG BORDER="0" SRC="Wing0a7300a700f033000000.png" HEIGHT="16" WIDTH="24" ALIGN="bottom" HSPACE="0" VSPACE="0">Experience with CMC regulations for biological compounds.</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>