Beacon Hill · 7 hours ago
Senior Manager, Regulatory Operations
United States
Full-time
Remote
Senior Level
7+ years expBeacon Hill is seeking a Senior Manager for Regulatory Operations to support oversight for global regulatory submission processes and systems management. The role focuses on ensuring regulatory submission excellence and compliance across multiple health authorities, while managing timelines and resources for regulatory submissions.
Staffing Agency
Responsibilities
Regulatory Information Management (RIM) systems management
Regulatory Publishing systems management
Lead and manage regulatory submission planning, publishing, and execution for global regulatory filings including INDs, CTAs, and future NDA/MAA submissions
Support the regulatory operations infrastructure, including eCTD publishing, document content templates, and Regulatory Information Management (RIM)
Manage timelines and resources for all regulatory submissions; ensure alignment with program goals and regulatory strategy
Support the implementation and continuous improvement of regulatory systems and processes (e.g., RIM, Publishing)
Maintain regulatory submission archives
Qualification
Required
Bachelor's degree in life sciences or equivalent required
7+ years of experience in Regulatory Operations within the biotech or pharmaceutical industry, with a focus on clinical-stage programs
Deep experience with eCTD publishing and global submission management (IND, CTA, BLA/NDA, MAA)
Strong knowledge of global regulatory requirements (FDA, EMA, ICH)
Proven experience working in a fast-paced, dynamic environment
Excellent project management and cross-functional collaboration skills
Proficiency with regulatory systems (e.g., Veeva Vault RIM, Lorenz, etc.)
Company
Beacon Hill
Beacon Hill was founded to set a new standard in search, career placement and flexible staffing.
1001-5000 employees
Funding
Current Stage
Late StageLeadership Team
Amber Leslie
Executive Assistant to CEO
Amy Van Sicklin
Chief Culture Officer
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