Job Overview A career as a Regulatory Affairs Specialist will allow you to make a significant impact on the product lifecycle. This role is responsible for ensuring compliance with regulatory requirements and developing strategies to expedite development for products addressing serious or life-threatening medical conditions. Key Areas of Responsibility: We are seeking an individual who can assess global, societal, and economic trends, stakeholder concerns, and regulatory issues, and their implications for regulatory strategy. You will develop and update global, regional, and multi-country regulatory strategies, aligning them with organizational goals. As a member of our team, you will provide guidance to integrate regulatory considerations into product entry and exit strategies. You will also identify pathways for initial product designs and provide input to stakeholders. Our ideal candidate has experience in analyzing proposed pathways and strategy for initial product designs, recommending changes or refinements based on outcomes. You will assess market access and distribution requirements and potential obstacles, developing solutions to address anticipated challenges. Additionally, you will critically assess the impact of changing regulations on preapproval and post-approval strategies and approaches. We are looking for someone who can negotiate with regulatory authorities on complex issues throughout the product lifecycle. Requirements and Qualifications: