Associate Manager, Regulatory Submissions

<h2>Job Overview:</h2><p style="margin: 0px;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Labcorp Drug Development is seeking candidates for an Associate Manager, Regulatory Submissions. The Associate Manager, Regulatory Submissions will be remotely (home-based) located within the United States or Canada with the east coast being the preferred location.</span></p><p style="margin: 0px;"> </p><p style="margin: 0px;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Responsible for the timely preparation of submissions to Regulatory Authorities in support of investigational and marketed products. Interacts with Regulatory Authorities and with clients to support regulatory activities. Proactively interacts with other Labcorp Drug Development groups and with clients to provide guidance regarding Regulatory Authority requirements and project timelines and </span><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">requirements. Working with minimal supervision, it is the responsibility of the Associate Manager to ensure that documents are prepared to the required standards by maintaining awareness of current regulatory standards related to drug submissions and clinical research, and be responsible for providing general Regulatory Authority submissions advice to client companies and/or the Labcorp Drug Development project team. May have supervisory responsibilities. May take on lead role primarily on a </span><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">regional level for medium to larger studies but can hold a global lead role depending upon experience level.</span></p><p style="margin: 0px;"> </p><ul><li><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Prepare study documentation such as the core EudraCT Form (Annex I, II & III) and cover letter.</span></li><li><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Prepare routine submissions filed to Regulatory Authorities (e.g. INDs/CTAs and NDAs/MAAs/CTDs). Will take ownership for specific pieces of work and may be the Regulatory Submissions lead for projects.</span></li><li><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Review/summarize scientific/research documents in preparation for submission to Regulatory Authorities.</span></li><li><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Assist in the coordination, collection and organization of data and information required by Regulatory Authorities.</span></li><li><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Interact with the Publishing group, Copy Center or equivalent as necessary for the production of submissions.</span></li><li><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Responsible for maintaining awareness of regulatory legislation, guidance and practice pertaining to Regulatory Authority submissions.</span></li><li><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Assure compliance with regulatory requirements in relation to assigned projects.</span></li><li><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Participate independently in client meetings and proactively liaise with clients on regulatory submission issues.</span></li><li><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">May take regional lead role primarily for small - medium/more complex projects but may also take global role as applicable on small / less complex studies.</span></li><li><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Mentor and coach other GRS team members.</span></li><li><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Participate in training of personnel.</span></li><li><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Provide regulatory submissions advice to external and internal teams.</span></li><li><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Assist in providing timely status on projects.</span></li><li><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">May represent Regulatory Submissions in new proposal opportunities.</span></li><li><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Work on special regulatory projects as assigned.</span></li></ul><h2>Education/Qualifications:</h2><p style="margin: 0px;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Recommended:</span></p><ul><li><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Bachelor’s Degree in Life Sciences or equivalent.</span></li></ul><h2>Experience:</h2><p style="margin: 0px;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Minimum Required:</span></p><ul><li><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Minimum 4 years of experience in the Pharmaceutical/CRO industry in Regulatory Affairs or Drug Development.</span></li></ul><p style="margin: 0px;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">#LI-REMOTE</span></p>