Global Regulatory Lead

Job ID: 25-60246Location: Madison, NJContact: Avinash MohantyContact Email: View email address on click.appcast.io Phone: 732 7437902Company: Mindlance Estimate Start Date July 7 th At LEO Pharma, our mission transcends the conventional. We're on an ambitious path to become the leaders in medical dermatology worldwide. If you're ready to make a difference, this role is your gateway to a world of opportunities! Your Role As a Global Regulatory Lead you will be overall accountable for global regulatory strategies and deliverables to development and life cycle management activities. Provide global regulatory leadership throughout the lifecycle of development and/or marketed product program(s). Ensure that input from global Health Authorities as well as regional and functional collaborators is collated to build a coherent, global, regulatory strategy which fulfills TPP and portfolio objectives. Develop comprehensive global regulatory strategies that takes into account worldwide regulatory requirement to drive product development, global registration, achievement of desired labeling, and effective regulatory agency interactions Lead Global Regulatory Teams (GRTs), with focus on developing high performance teams Provide regulatory expertise and guidance to project teams Represent Regulatory Affairs in cross-functional project teams Maintain expert knowledge on regulatory environment, guidelines, competitor landscape in the US, EU, and key international markets Plan and execute global regulatory submissions (e.g., MAA/NDA, CTA/IND, label extensions, PIP/PSP) Review/approve key regulatory documents (e.g., briefing documents,, documents for regulatory submissions , core labeling) Your Qualifications Master’s or Bachelor’s degree in Natural Sciences (Master’s preferred) or equivalent 10+ years of experience in the pharmaceutical industry with increasing global strategic regulatory responsibilities Proven track record of leading key regulatory milestones (e.g., EOP2, MAA/NDAs, line extensions) with major business impact Strong knowledge of global regulatory frameworks across both development and life cycle management phases Expert understanding of ICH guidelines and major health authority requirements (US, EU, Japan, China) Broad business acumen and understanding of project impact Strategic thinker with a curious, proactive, and solution-oriented mindset Strong team player and effective communicator Skilled in stakeholder management, balancing multiple priorities High personal drive, positive attitude, and strong commitment