Sr. Associate, Regional Regulatory Strategist (RRS) - Global Brands

<p><b>JOB SUMMARY</b></p><p></p><p></p><p>This position is responsible for developing and implementing European, Rest of World (ROW) or US regulatory strategy that aligns with business needs. The purpose of this role is to:</p><ul><li><p>Work across GRS functions supporting key regulatory tasks and deliverables across programs, disease areas, and region(s) for regulatory affairs (US, EU and/or EM).</p></li><li><p>Provide regional input and build regulatory expertise for products in the assigned region as a member of the Global Regulatory Strategic Team (GRST) level.</p></li><li><p>Support implementation activities of global/regional regulatory and labeling strategies in agreement with key stakeholders for assigned projects/products and in line with the commercial goals.</p></li><li><p>Be accountable for timely planning, preparation, submissions and approvals of program(s) deliverables in the designated region.</p></li><li><p>Be accountable for ensuring optimal regulatory interactions with Health Authorities in relation to the assigned project(s) within designated region.</p></li><li><p>Role can be combined with other GRS function activities based upon priorities.</p></li><li><p>Project(s) assigned can be in various development stages, but mostly in early <span>development/registration</span> and/or at post-authorization stage across categories.</p></li></ul><p></p><p><b>JOB RESPONSIBILITIES </b></p><p></p><ul><li><p>Supports regional (US, EU and/or EM) above country contribution to Global Regulatory Strategies and implementation plans (including core labels, risk registers, intellligence) for assigned project(s) across categories.</p></li><li><p>Works across programs with the assigned region/countries to support INDs / CTAs / renewals  life cycle activities in the preparation and submission activities, regulatory systems updates and compliance, regulatory correspondence archiving, rapid response team activities, and other duties as assigned.</p></li><li><p>Ensures regulatory contributions achieve the objectives in the strategy, achieve agreed standards, maximizing overall project delivery time and probability of success and facilitating post filing activities.</p></li><li><p>Partners with project teams and other customer groups (e.g. BU, Regional Commercial Teams) to ensure required regulatory contributions (line plans, label, MAA/IRD, variations, license renewals etc) meet business needs and are provided to the project teams, to agreed time and quality standards.</p></li><li><p>Ensures regulatory plans are monitored, progress/variance communicated to GRL and Senior Management and any risks (from emerging technical data, changing internal objectives or external threats) mitigated.</p></li><li><p>Ensures an aligned regional regulatory position is reached and communicated for all key issues for assigned project/s, and that these regulatory positions supporting the regional business are championed and communicated.</p></li><li><p>Engages in appropriate activities in order to influence the regional regulatory environment through GRS-In Country colleagues, Agency contacts and/or Trade Associations as appropriate.</p></li><li><p>Ensures business compliance and implementation of and adherence to Regulatory standards</p></li><li><p>Develops and maintains, directly or indirectly, constructive working relationship with Health Authority contacts in the assigned region(s)</p></li></ul><p></p><p><b>QUALIFICATIONS / SKILLS</b></p><p></p><ul><li><p>Bachelors degree in a scientific field required</p></li><li><p>Miminimum of 2 years of experience</p></li><li><p>PharmD / PhD / MSc preferred</p></li><li><p>Knowledge of drug development practice rules, regulations and guidelines - familiarity with factors likely to influence the regulatory environment, including new and emerging guidelines</p></li><li><p>Career aspiration in developing and implementing regulatory strategy – Basic understanding of regulatory agency philosophy and guidelines. Experience preparing and submitting, supplements and variations to NDAs / MAA/IRDs desirable. Understanding of key concepts of product label aligned to target product profile and corporate expectations. Prior experience working with regulator(s)</p></li><li><p>Communication skills - Ability to communicate complex information and analyses to a variety of scientific audiences in both verbal and written format, including to senior management</p></li><li><p>Presentation skills - Is effective in a variety of formal presentation settings; one-on-one, small and large groups, with peers, direct reports and senior managers</p></li><li><p>Negotiation skills - Can negotiate skillfully and diplomatically in tough situations with both internal and external groups. Gains trust quickly of other parties to the negotiations</p></li></ul><p></p><p><b>ORGANIZATIONAL RELATIONSHIPS</b></p><p></p><ul><li><p>Reports to relevant assigned Mgr/Sr. Mgr./ Director/Sr Dir</p></li><li><p>Works with GRS colleagues and re