The Steely Group · 10 hours ago
Director Global Regulatory Affairs
Greater Boston
Full-time
Onsite
Director/Executive
$225K/yr - $275K/yr
10+ years expThe Steely Group is seeking a Director of Global Regulatory Affairs to lead the creation and execution of regulatory strategies aligned with internal objectives. This role involves overseeing regulatory initiatives, ensuring compliance with global standards, and providing expert guidance to internal stakeholders to support product development and commercialization.
ConsultingHealth CareHuman ResourcesMedicalStaffing Agency
Hiring Manager
Tracey Goldthwaite
Responsibilities
Act as the Global Regulatory Lead within the cross-functional core team
Contribute to the overarching global regulatory strategy across programs
Develop regulatory development plans for assigned projects and oversee regulatory timelines
Take charge of planning and drafting content for submissions to Regulatory Agencies (such as INDs, CTAs, meeting requests, briefing documents, Pediatric Investigation Plans, and annual reports), and coordinate responses to regulatory inquiries
Serve as the primary liaison between the company and Regulatory Agencies for designated projects
Ensure regulatory filings are completed efficiently, on time, and in accordance with applicable standards and commitments
Expand and maintain expertise regarding US, EU, and ROW regulations relevant to assigned programs
Keep cross-functional team members informed about new regulations, standards, policies, and guidance from Regulatory Agencies that could impact the company
Conduct literature searches, prepare reports, and gather documentation to support project teams when needed
Assist in developing and updating departmental procedures, policies, SOPs, and related documents
Participate in efforts focused on improving internal standards and systems
Qualification
Required
Bachelor of Science (BS) degree required, and graduate degree is preferred
At least 10 years of regulatory affairs experience in drug development within the pharmaceutical or biotechnology industry. Experience should include work across multiple phases of development and ideally encompass both large and small company environments
Demonstrated expertise with regulatory programs for products addressing rare diseases and/or unmet medical needs—such as orphan products, fast track, breakthrough therapies, or PRIME designations—is required
Strong experience with the U.S. Food and Drug Administration (FDA) is essential
Full functional knowledge of regulatory requirements—including regulations, directives, and guidance/guidelines—pertaining to the development and registration of drug products in multiple International Council for Harmonisation (ICH) regions is essential
The ideal candidate will be able to set priorities, work independently, and deliver results within established timelines
Strong organizational and planning skills are necessary, along with the ability to communicate effectively and efficiently with multiple audiences
Preferred
Graduate degree is preferred
Experience working with the European Medicines Agency (EMA) or other regional regulatory bodies is preferred
The role requires evidence of critical strategic thinking and a solution-oriented approach, with the ability to think creatively. Preference will be given to individuals who can demonstrate these skills within rare disease programs
Company
The Steely Group
The Steely Group offers clinical, healthcare, and human resource recruitments and staffing solutions.
11-50 employees
Funding
Current Stage
Early StageLeadership Team
Giovanni Oriente
Chief Financial Officer
Jay VanHousen
Sr Director, Clinical and Scientific Partnerships
Recent News
2025-10-23
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