Sr. Associate Regulatory Submissions

<p><b>Job Summary:</b></p><p> 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 Covance groups and with clients to provide guidance regarding Regulatory Authority requirements and project timelines and requirements. Working with minimal supervision, it is the responsibility of the Senior Regulatory Associate to prepare documents to the required standard and to maintain awareness of current regulatory standards related to submissions for drug and biologic products. May have supervisory responsibilities.</p><p></p><p><b>Essential Job Duties: </b></p><p>♦ Prepare study documentation such as the core EudraCT Form (Annex I, II & III) and cover</p><p>letter.</p><p>♦ Prepare routine submissions filed to Regulatory Authorities (e.g. INDs/CTAs and</p><p>NDAs/MAAs/CTDs). Will take ownership for specific pieces of work and may be the</p><p>Regulatory Submissions lead for projects.</p><p>♦ Review/summarize scientific/research documents in preparation for submission to Regulatory</p><p>Authorities.</p><p>♦ Assist in the coordination, collection and organization of data and information required by</p><p>Regulatory Authorities.</p><p>♦ Interact with the Publishing group, Copy Center or equivalent as necessary for the production</p><p>of submissions.</p><p>♦ Responsible for maintaining awareness of regulatory legislation, guidance and practice</p><p>pertaining to assigned product/project areas.</p><p>♦ Assure compliance with regulatory requirements in relation to assigned projects.</p><p>♦ Participate in project development and regulatory strategy planning sessions. Will participate</p><p>independently in client meetings and will proactively liaise with clients on regulatory</p><p>submission issues.</p><p>♦ Work on special regulatory projects as assigned.</p><p><b>Experience: </b></p><p>Minimum Required:</p><p>♦ Minimum of 3 years experience in the Pharmaceutical industry in Regulatory Affairs or Drug</p><p>Development</p><p></p><p><b>Education/Qualifications/Certifications and Licenses </b></p><p>Recommended:</p><p>♦ Bachelor’s Degree in Life Sciences or equivalent</p><p></p><p></p><p><b>Labcorp is proud to be an Equal Opportunity Employer:</b></p><p></p><p>As an EOE/AA employer, the organization will not discriminate in its employment practices due to an applicant's race, age, color, religion, sex, national origin, sexual orientation, gender identity, disability or veteran status.</p><p></p><p>For <span>more information about how we collect and store your personal data, please see our </span><span><a href="https://www.labcorp.com/hipaa-privacy/web-privacy-policy" target="_blank">Privacy Statement</a></span><a href="https://www.labcorp.com/hipaa-privacy/web-privacy-policy" target="_blank"><span>.</span></a><span> </span></p>