Regulatory Affairs Lead, Project Manager

You are being sought after to take on the role of Regulatory Affairs Lead/ Project Manager, joining a dynamic team that values passionate regulatory professionals. Your main responsibilities will include managing regulatory projects for Pharmaceuticals, Biologics, Medical Devices, and other products in Global Markets. You will be expected to plan and prepare regulatory project plans/submission strategies, lead regulatory submissions, manage interactions with Health Authorities across multiple regions, and provide clear guidance to cross-functional teams by identifying regulatory gaps and assessing risks. Additionally, you will work closely with Regional Regulatory Experts, act as the primary point of contact for clients, drive project planning and execution, collaborate with business development teams, and mentor junior team members to foster a culture of excellence and accountability. Qualifications you should possess for this role include having 4-7 years of experience in regulatory affairs and project management within the pharmaceutical, biotech, or medical device sectors. You should have a deep understanding of client strategic requirements against global regulatory and documentation requirements, a proven track record of preparing and submitting applications to regional/global Health Authorities, strong client-facing and stakeholder management skills, and an entrepreneurial mindset with excellent organizational, communication, and leadership skills. In addition to the role specifics, this opportunity offers you the chance to work on diverse global projects across multiple markets in a collaborative, growth-oriented, and innovative work culture. You will have a platform to take ownership, lead client interactions, and contribute to global healthcare access.,