Legend Biotech · 15 hours ago
Senior Manager, Regulatory Strategy
Somerset, New Jersey, United States
Full-time
Onsite
Mid, Senior Level
$124K/yr - $162K/yr
2+ years expLegend Biotech is a global biotechnology company dedicated to treating life-threatening diseases, headquartered in Somerset, New Jersey. The Senior Manager, Regulatory Strategy will lead the development and execution of global regulatory strategies, manage regulatory submissions, and provide strategic regulatory guidance to cross-functional teams.
BiotechnologyHealth CareLife ScienceOncologyTherapeutics
Responsibilities
Lead the preparation, submission, management and maintenance global regulatory submissions including IND / CTAs, amendments, information requests, Orphan Drug Applications, DSUR / IB, and Marketing Applications etc
Coordinate and prepare for Agency meetings and meeting package preparation
Provide strategic regulatory input on clinical development plans, CMC strategies, and nonclinical programs to support regulatory milestones
Contribute to regulatory intelligence and interpretation of evolving global regulatory requirements, guidances, and precedents
Manage regulatory queries and commitments, works with experts on responses, and provides regular status updates
Identifies regulatory risks and creates mitigation plans
Develop and draft regulatory strategy components, analyses, and position statements
Interpret health authority feedback and propose recommended paths forward for internal discussion
Provide routine regulatory guidance to cross-functional teams on applicable regulations, guidances, and precedents
Manage day-to-day regulatory activities and timelines for assigned deliverables
Qualification
Required
Bachelor's degree in life sciences or related field
At least 2 years in regulatory strategy
Ex-US regulatory submission experience
Understanding of global regulatory frameworks (FDA, EMA, ICH)
Excellent written and verbal communication skills
Advanced proficiency with Word
Preferred
Advanced degree (doctorate or masters) is preferred
Benefits
Medical, dental, and vision insurance
401(k) retirement plan with a company match that vests fully on day one
Eight (8) weeks of paid parental leave after just three (3) months of employment
Paid time off policy that includes vacation time, personal time, sick time, floating holidays, and eleven (11) company holidays
Flexible spending and health savings accounts
Life and AD&D insurance
Short- and long-term disability coverage
Legal assistance
Supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance
Commuter benefits
Family planning and care resources
Well-being initiatives
Peer-to-peer recognition programs
Company
Legend Biotech
Legend Biotech is a biopharmaceutical company that develops and commercializes novel cell therapies for oncology.
1001-5000 employees
H1B Sponsorship
Legend Biotech has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (30)
2024 (11)
2023 (14)
2022 (7)
2021 (6)
2020 (13)
Funding
Current Stage
Public CompanyTotal Funding
$750.45M2023-05-05Post Ipo Equity· $350M
2022-07-25Post Ipo Equity· $250M
2020-06-05IPO
Leadership Team
Carlos Santos
Chief Financial Officer
Alan Bash
President, CARVYKTI
Recent News
legacy.thefly.com
2026-01-22
2026-01-22
Company data provided by crunchbase