Manager - 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=320 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> <bR> <bR> <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. Dir/VP "Phase 1 Leader"</U></A></div> <div> <A HREF="id102.htm" TARGET="_top" TITLE="Dir., Multiple Myeloma Marketing"><U>Dir., Multiple Myeloma Marketing</U></A></div> <div> <A HREF="id101.htm" TARGET="_top" TITLE="VP Clinical and Medical Affairs"><U>VP Clinical and Medical Affairs</U></A></div> <div> <A HREF="id100.htm" TARGET="_top" TITLE="Senior Dir., Translational Medicine"><U>Senior Dir., Translational Medicine</U></A></div> <div> <A HREF="id99.htm" TARGET="_top" TITLE="Director Medical Affairs Oncology"><U>Director Medical Affairs -- Oncology</U></A></div> <div> <A HREF="id98.htm" TARGET="_top" TITLE="Clinical Submission Manager"><U>Clinical Submission Manager</U></A></div> <div> <A HREF="id97.htm" TARGET="_top" TITLE="Senior BiostatisticianProgrammer Pharma"><U>Senior Biostatistician-Programmer - Pharmacovigilance </U></A></div> <div> <A HREF="id96.htm" TARGET="_top" TITLE="Senior Medical Reviewer, Drug Safety "><U>Senior Medical Reviewer, Drug Safety </U></A></div> <div> <A HREF="id95.htm" TARGET="_top" TITLE="Director, Solid Tumor Marketing"><U>Director, Solid Tumor Marketing</U></A></div> <div> <A HREF="id94.htm" TARGET="_top" TITLE="Director, Regulatory CMC"><U>Director, Regulatory CMC</U></A></div> <div> <A HREF="id93.htm" TARGET="_top" TITLE="Director IM Forecasting and Planning"><U>Director IM Forecasting and Planning</U></A></div> <div> <A HREF="id92.htm" TARGET="_top" TITLE="Senior Mgr., IVRS Central Management"><U>Senior Mgr., IVRS Central Management</U></A></div> <div> <A HREF="id91.htm" TARGET="_top" TITLE="Manager, Safety Quality Assurance, Globa"><U>Manager, Safety Quality Assurance, Global Drug Safety</U></A></div> <div> <A HREF="id90.htm" TARGET="_top" TITLE="Research Scientist I / II"><U>Research Scientist I / II</U></A></div> <div> <A HREF="id88.htm" TARGET="_top" TITLE="Associate Director/Director, Regulatory "><U>Associate Director/Director, Regulatory Affairs, Oncology</U></A></div> <div> <A HREF="id75.htm" TARGET="_top" TITLE="AD/Trail Management, Translational Medic"><U>AD/Trail Management, Translational Medicine(TM)</U></A></div> <div> <A HREF="id72.htm" TARGET="_top" TITLE="Associate Director, Regulatory Affairs, "><U>Associate Director, Regulatory Affairs, Oncology</U></A></div> <div> <A HREF="id71.htm" TARGET="_top" TITLE="Associate Director, Manufacturing Operat"><U>Associate Director, Manufacturing Operations</U></A></div> <div> <A HREF="id53.htm" TARGET="_top" TITLE="Compliance Project Sr. Specialist "><U>Compliance Project Sr. Specialist </U></A></div> <div> <A HREF="id65.htm" TARGET="_top" TITLE="Senior Director, Lead Global Product Saf"><U>Senior Director, Lead Global Product Safety Physician </U></A></div> <div> <A HREF="id76.htm" TARGET="_top" TITLE="Senior Medical Reviewer, Drug Safety"><U>Senior Medical Reviewer, Drug Safety</U></A></div> <div> <A HREF="id52.htm" TARGET="_top" TITLE="Director, Lead Global Product Safety Phy"><U>Director, Lead Global Product Safety Physician </U></A></div> <div> <A HREF="id86.htm" TARGET="_top" TITLE="Clinical Research Scientist, Oncology"><U>Clinical Research Scientist, Oncology</U></A></div> <div> <A HREF="id85.htm" TARGET="_top" TITLE="Associate Director, GLP Quality Assuranc"><U>Associate Director, GLP Quality Assurance </U></A></div> <div> <A HREF="id84.htm" TARGET="_top" TITLE="Medical Writer, Scientific Communication"><U>Medical Writer, Scientific Communications</U></A></div> <div> <A HREF="id81.htm" TARGET="_top" TITLE="Director/Sr. Director, Regulatory Affair"><U>Director/Sr. Director, Regulatory Affairs</U></A></div> <div> <A HREF="id80.htm" TARGET="_top" TITLE="Associate Director, Manufacturing Ops"><U>Associate Director, Manufacturing Ops</U></A></div> <div> <A HREF="id79.htm" TARGET="_top" TITLE="Manager, Nonclinical Development Q.A."><U>Manager, Nonclinical Development Q.A.</U></A></div> <div> <A HREF="id78.htm" TARGET="_top" TITLE="Clinical Research Physician Oncology/Hem"><U>Clinical Research Physician- Oncology/Hematology</U></A></div> <div> <A HREF="id77.htm" TARGET="_top" TITLE="Clinical Research Physician Inflammation"><U>Clinical Research Physician- Inflammation</U></A></div> <div> <A HREF="id59.htm" TARGET="_top" TITLE="Quality System Application Specialist"><U>Quality System Application Specialist</U></A></div> <div> <A HREF="id87.htm" TARGET="_top" TITLE="Assoc Director DMPK"><U>Assoc Director DMPK</U></A></div> <div> <A HREF="id83.htm" TARGET="_top" TITLE="Mgr., Global Project Mgt. Admin."><U>Mgr., Global Project Mgt. Admin.</U></A></div> <div> <A HREF="id82.htm" TARGET="_top" TITLE="Project Manager Clinical Supplies"><U>Project Manager Clinical Supplies</U></A></div> <div> <A HREF="id73.htm" TARGET="_top" TITLE="M.D. Medical Safety Expert"><U>M.D. - Medical Safety Expert</U></A></div> <div> <A HREF="id64.htm" TARGET="_top" TITLE="Sr. Manager, Manager Pharmacokinetics"><U>Sr. Manager, Manager Pharmacokinetics</U></A></div> <div> <A HREF="id60.htm" TARGET="_top" TITLE="Manager/Sr. Mgr. Q.C. Laboratory"><U>Manager/Sr. Mgr. - Q.C. Laboratory</U></A></div> <div> <A HREF="id74.htm" TARGET="_top" TITLE="Investigation Mgr., Devel. Quality"><U>Investigation Mgr., Devel. Quality</U></A></div> <div> <A HREF="id47.htm" TARGET="_top" TITLE="Clinical Pharmacology Scientist"><U>Clinical Pharmacology Scientist</U></A></div> <div> <A HREF="id55.htm" TARGET="_top" TITLE="Global Product Safety Physician"><U>Global Product Safety Physician</U></A></div> <div> <A HREF="id63.htm" TARGET="_top" TITLE="Assoc. Director Global Drug Safety"><U>Assoc. Director - Global Drug Safety</U></A></div> <div> <A HREF="id61.htm" TARGET="_top" TITLE="Sr. Prin/Assoc. Dir. Biostatistics"><U>Sr. Prin/Assoc. Dir. - Biostatistics</U></A></div> <div> <B><IMG BORDER="0" SRC="Symb075c00b700f0ccffff00.png" HEIGHT="16" WIDTH="24" ALIGN="bottom" HSPACE="0" VSPACE="0">Manager - Regulatory Affairs</B></div> <div> <A HREF="id69.htm" TARGET="_top" TITLE="Senior Director Clinical Ops"><U>Senior Director - Clinical Ops</U></A></div> <div> <A HREF="id70.htm" TARGET="_top" TITLE="Senior Research Scientist"><U>Senior Research Scientist</U></A></div> <div> <A HREF="id68.htm" TARGET="_top" TITLE="Senior Mgr., Med. Sci. 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> <bR> <bR> <bR> </td> <td valign="top" height=398 BGCOLOR="#FFFFCC" TEXT="#080000"> <div> <B><U>Manager - Regulatory Affairs</U></B></div> <bR> <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= 753 ><NOBR><bR> <bR> <div> <B>Manager</B></div> <div> <B>Regulatory Affairs</B></div> <bR> <div> <B>Posted June 22, 2005</B></div> <bR> <div> <B><IMG SRC="0e396330.jpg" border=0 width="150" height="51" ALIGN="BOTTOM" HSPACE="0" VSPACE="0"></B></div> <bR> <div> <B>3 to 5 Years Experience</B></div> <bR> <div> <B>Parsippany, NJ</B></div> <div> <B> </B></div> <bR> <bR> <bR> </NOBR></tD> <tD VALIGN=CENTER BGCOLOR=#FFFFFF WIDTH="386"><div> <B>JOB DESCRIPTION: </B></div> <div> The Manager of Regulatory Affairs will manage department responsibilities as well as project assignments within product categories including managing or assisting in the coordination, review, compilation, assembly, filing and tracking of applications through the FDA review process to assure rapid review and approval. The Manager will also be responsible for management of assigned monograph and nutritional products </div> <div> Specific responsibilities include: </div> <div> • Implement regulatory strategies pertaining to specific projects to expedite the development, filing, regulatory approval, as well as the protection and continued marketing of existing products. Manage all phases of assigned monograph and nutritional products. </div> <div> • Represent Regulatory on assigned project teams, supplying appropriate advice and support to ensure compliance with all regulatory requirements. </div> <div> • Review and approve assigned product labeling, advertising and promotional materials, ensuring full compliance with all applicable FDA and FTC regulations and industry guidelines. </div> <div> • Compile, assemble, and file documentation for new or existing products to regulatory authorities to assure all submissions are of high quality, presented in a manner to facilitate review, and in conformance with appropriate regulations and guidelines. Track submissions, initiating internal communications to adequately respond to agency inquiries and requests.</div> <bR> <div> <B>JOB REQUIREMENTS:</B> </div> <div> The successful candidate must have: </div> <div> - Strong working knowledge of the drug development process and all regulations and guidelines applicable to OTC drugs including IND and NDA compilation and filing requirements. </div> <div> - Labeling and advertising and promotional requirements; and GMPs. </div> <div> - Minimum of three to five years of pharmaceutical or OTC regulatory affairs experience. </div> <div> - Good communication (oral and written) and negotiation skills along with demonstrated team skills. </div> <div> - Must be capable of preparing and presenting technical reports and analyses. </div> <div> - Self-motivated, reliable, ethical and well organized in thought and word.</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>