This job was posted by https://www.kansasworks.com : For more information, please see: https://www.kansasworks.com/jobs/13707076 Job Description: Global Regulatory Lead Location: Remote Role Overview The Regulatory Specialist provides strategic regulatory leadership for a late-stage cardiovascular development program, serving as the primary regulatory lead for a key investigational asset. This role drives global regulatory strategies through critical development and registration milestones, including NDA preparation, submission, and review activities. The successful candidate will leverage a strong background in cardiovascular drug development to lead complex matrix teams and navigate key regulatory pathways. Key Responsibilities - Serve as the regulatory lead for a late-stage cardiovascular development program, establishing and executing global regulatory strategies. - Provide strategic leadership throughout key development milestones, including Database Lock, NDA preparation, and submission activities. - Lead and facilitate internal and joint regulatory teams, driving collaboration, decision-making, and execution across partner organizations. - Drive regulatory readiness and execution for original NDA submissions, ensuring cross-functional alignment and risk mitigation. - Develop product registration strategies and translate them into actionable operational plans. - Develop and execute asset-specific health authority engagement strategies, leading interactions with global regulatory agencies. - Serve as a regulatory subject matter expert, providing strategic guidance on agency communications and submission approaches. - Collaborate with clinical, nonclinical, biostatistics, and development teams to ensure regulatory considerations are incorporated into program plans. - Provide strategic regulatory input to Clinical Study Protocols, Clinical Study Reports, and nonclinical summaries. - Contribute to the development of Target Product Profiles, Company Core Data Sheets, and global labeling strategies. Required Qualifications Education: A PhD, MD, PharmD, MS, or BS in a relevant scientific discipline. Experience: Significant experience in Regulatory Affairs, typically 4 or more years, with a proven track record supporting cardiovascular drug development programs. Technical Skills: Prior experience serving as a Global Regulatory Lead, with demonstrated experience leading major regulatory submissions and health authority interactions. Global regulatory experience spanning multiple regions, such as the European Union, Japan, Australia, and other countries. Preferred Qualifications - Proven success developing and implementing global regulatory strategies that support clinical development and product registration. - Strong experience communicating regulatory strategy, risks, and recommendations to senior leadership and cross-functional stakeholders. - Demonstrated ability to lead complex matrix teams across multiple functions and geographies. - Proven success negotiating regulatory objectives with global health authorities. Everforth Apex is a world-class IT services company that serves thousands of clients across the globe. When you join Everforth Apex, you become part of a team that values innovation, collaboration, and continuous learning. We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package. Our commitment to excellence is reflected in many awards, including ClearlyRateds Best of Staffing in Talent Satisfaction in the United States and Great Place to Work in the United Kingdom and Mexico. Everforth Apex uses a virtual recruiter as part of the application process. Click here{target="_blank" rel="noopener"} for more details. By applying for this job, you agree to receive calls, AI-generated calls, text messages, or emails from Everforth Apex and its affiliates, and contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You can reply STOP to cancel and HELP for help. You can access our privacy policy at https://www.apexsystems.com/privacy-policy{target="_blank" rel="noopener"} Everforth Apex Benefits Overview: Everforth Apex offers a range of supplemental benefits, including medical, dental, vision, life, disability, and other insurance plans that offer an optional layer of financial protection. We offer an ESPP (employee stock purchase program) and a 401K program which allows you to contribute typically within 30 days of starting, with a company match after 12 months of tenure. Everforth Apex also offers a HSA (Health Savings Account on the HDHP plan), a SupportLinc Employee Assistance Program (EAP) with up to 8 free counseling sessions, a corporate discount savings program and other discounts. In terms of
