Client dedicated Global Regulatory Lead - Early Development

Job description

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description The Global Regulatory Lead, Early Development is a key member of the global regulatory team and a close business partner to the client’s early development organization. This client-embedded role provides strategic, operational, and hands-on regulatory leadership for assigned programs, with a primary focus on early clinical development—from first-in-human planning through initial clinical studies and early clinical proof of concept. Working closely with scientists, clinicians, and cross-functional development teams, the Global Regulatory Lead helps shape global regulatory strategies and supports decisions on how programs advance through early clinical development. The role also connects early-stage programs with the broader regulatory and development organizations as assets progress. Your primary areas of focus are:Provide strategic, operational, and tactical regulatory insight for assigned programs, focusing on first-in-human planning and early clinical development. Develop and communicate global regulatory strategies for early clinical programs, including the regulatory approach to initial clinical studies and key early development milestones. Advise teams on regulatory requirements and development plans, including how the nonclinical package supports first-in-human decisions. Deep preclinical expertise is not required. Represent the regulatory function on assigned project teams and in relevant governance forums, helping stakeholders make informed development and portfolio decisions. Partner with scientists, clinicians, and cross-functional colleagues to coordinate regulatory activities and provide timely input as programs move through early clinical development. Contribute to regulatory documents and submissions, including INDs, CTAs, scientific advice requests, and other early development filings, as needed. Support high-quality interactions with health authorities, particularly the FDA and EMA, and help teams prepare for those interactions. Serve as a conduit between assigned project teams, the client’s early development organization, and the broader global regulatory and development teams, supporting continuity as assets progress. Monitor, interpret, and communicate changes in relevant global regulations, guidelines, and health authority expectations. Support regulatory vendor oversight and help ensure high-quality deliverables and interactions with health authorities. Contribute to improvements in regulatory processes and ways of working, and support colleagues through mentoring and knowledge sharing. Desired Skills and ExperienceMinimum 10 years of regulatory affairs experience within biopharmaceutical organizations, including 5–7 years in global regulatory leadership roles focused on major regions such as the FDA, EMA, or PMDA. PhD or PharmD preferred. Thorough understanding of drug development, with strong global regulatory experience in early clinical development, including first-in-human planning and initial clinical studies. Demonstrated ability to shape bold, innovative global regulatory strategies for early clinical programs and translate them into practical development plans. Ability to assess how the nonclinical package supports first-in-human decisions; deep preclinical expertise is not required. Demonstrated ability to coordinate critical regulatory documents and submissions supporting early clinical development, with a focus on the FDA. Experience interacting with regulatory and health authorities, especially the FDA and EMA. Knowledge of orphan drug development and the evolving regulatory landscape, particularly in the United States. Scientific curiosity and the ability to engage credibly with scientists and clinicians on technical and business topics. Familiarity with current and emerging regulatory legislation, industry trends, and healthcare business practices globally. Strong organizational and project management skills, including strategic planning, prioritization, and coordination across multiple workstreams. Clear written and verbal communication skills, with the ability to present complex regulatory topics and influence stakeholders effectively. A collaborative approach to building relationships and partnering across functions to achieve shared goals. Ability to work effectively in a fast-paced, results-driven, highly accountable environment. A pragmatic, creative, hands-on approach, combining strategic thinking with the ability to execute independently and through matrix teams.