Regulatory Affairs Lead, Project Manager

As a Regulatory Affairs Lead/ Project Manager, you will play a crucial role in managing clients" regulatory projects for Pharmaceuticals, Biologics, Medical Devices, and other products in global markets. Your responsibilities will include planning and preparing regulatory project plans/submission strategies, leading regulatory submissions, managing interactions with Health Authorities across multiple regions, identifying regulatory gaps, assessing risks, and providing clear guidance to cross-functional teams. You will work closely with Regional Regulatory Experts, provide directions, identify gaps, and offer strategic direction. Additionally, you will act as the primary point of contact for clients, ensuring proactive and effective communication, driving project planning, execution, and monitoring to ensure timely and compliant delivery. Collaboration with business development teams to support proposals and regulatory strategy discussions will also be part of your role. Moreover, you will mentor and guide junior team members, fostering a culture of excellence and accountability. Qualifications: - 4-7 years of experience in regulatory affairs and project management within the pharmaceutical, biotech, or medical device sectors. - Deep understanding of client strategic requirements against global regulatory and documentation requirements. - Proven track record of preparing and submitting applications to regional/global Health Authorities. - Strong client-facing and stakeholder management skills. - Entrepreneurial mindset: self-starter, problem-solver, and capable of driving initiatives independently. - Excellent organizational, communication, and leadership skills. By joining our team, you will have the opportunity to work on diverse global projects across multiple markets. You will be part of a collaborative, growth-oriented, and innovative work culture that provides a platform to take ownership, lead client interactions, and contribute to global healthcare access.,