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 Experience
- Minimum 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.