Director/Senior Director - Global Regulatory Affairs Strategy

<h2>Job Overview:</h2><p style="margin: 0px;"><span style="font-size: 10pt;">Labcorp Drug Development is looking for a Director/Senior Director - Global Regulatory Affairs Strategy to join the team, candidates can be based anywhere in Europe.</span></p><p style="margin: 0px;"><span style="font-size: 10pt;"> </span></p><p style="margin: 0px;"><span style="font-size: 10pt;">The Director/Senior Director of Global Regulatory Affairs Strategy, Product Development Consulting will work closely with sponsor companies in developing regulatory strategies that will support drug development initiatives. This responsibility will include leading client interactions with regulatory agencies globally. This position will also work as an internal consultant/advisor across various LabCorp Drug Development business units to facilitate dialogue with our clients to develop relevant regulatory strategy and tactic plans to meet their drug development needs globally.</span></p><p style="margin: 0px;"><span style="font-size: 10pt;"><span style="color: black;"><span style="font-size: 10.0pt;"><strong><span style="font-size: 10.0pt; font-family: 'Arial',sans-serif; color: black;"><span style="font-size: 11.0pt; font-family: 'Calibri',sans-serif;"><span style="font-size: 10.0pt; font-family: 'Arial',sans-serif;">#LI-NC1 REMOTE</span></span></span></strong></span></span></span></p><h2>Education/Qualifications:</h2><p style="margin: 0px;"><span style="font-family: verdana, geneva; font-size: 10pt;">Bachelors degree in a life science, pharmacy or medicine is required.  PharmD, MD or PhD in a life science, pharmacy or medicine is preferred.</span></p><h2>Experience:</h2><p style="margin: 0px;"><span style="font-size: 10pt;">8-10 years experience of drug development in the Pharma, biotech or CRO industry with at least 6-8 years experience in regulatory affairs developing global regulatory strategies for early and late stage development programs.</span></p><p style="margin: 0px;"> </p><ul><li><span style="font-size: 10pt;">Experience in discovery research, preclinical pharmacology, toxicology, or clinical research required.</span></li><li><span style="font-size: 10pt;">Proven history of finding novel solutions to challenging drug development issues and developing innovative regulatory strategies.</span></li><li><span style="font-size: 10pt;">Knowledge of regulatory guidance in multiple regions and industry best practices for drug development</span></li><li><span style="font-size: 10pt;">Experience with leading strategic planning, preparation and execution of Agency interactions.</span></li><li><span style="font-size: 10pt;">Experience leading teams through IND, CTA development, addressing agency questions to support the start up of clinical trials</span></li><li><span style="font-size: 10pt;">Experienced in leading teams through NDA/MAA development, submission and addressing Agency inquiries.</span></li><li><span style="font-size: 10pt;">Leadership role in HA negotiations in multiple regions/countries.</span></li><li><span style="font-size: 10pt;">The ability to develop effective multi-cultural relationships.</span></li><li><span style="font-size: 10pt;">Global people management/leadership experience required</span></li><li><span style="font-size: 10pt; font-family: verdana, geneva;">Excellent organizational skills and the ability to manage multiple important projects with tight timelines is essential.</span></li></ul>