Jazz Pharmaceuticals · 6 hours ago
Senior Manager, Regulatory Strategy
United States
Full-time
Remote
Senior Level
$140K/yr - $210K/yrJazz Pharmaceuticals is a global biopharma company dedicated to developing life-changing medicines for serious diseases. The Senior Manager, Regulatory Strategy will support product applications and be a key member of project teams, establishing regulatory strategies and managing submissions for commercial products.
BiotechnologyHealth CarePharmaceutical
Responsibilities
Participate as an active member of a multi-disciplinary team to establish development and regulatory strategies for commercial products, late stage, and early stage development programs. Identify and communicate potential risks associated with strategy scenarios
Represent and coordinate regulatory information as a team member, covering CMC, clinical, labeling, and post-approval change activities
Provide in-depth reviews of protocols, reports, presentations, and other documents
Document regulatory contacts with health authorities
Prepare IND, NDA, and BLA submissions including original marketing applications, clinical trial applications, amendments, supplements, variations, responses to Agency questions and requests, meeting requests, briefing packages, annual reports, periodic safety reports, etc. Help manage the internal review and submission of these items
Ensure consistency/completeness/accuracy, and adherence to regulations and applicable guidelines for all regulatory submissions
Manage submission plans and timelines to ensure approvals are timely and development objectives are met
Review and interpret recent product approvals, current regulatory guidance documents, and recent public Advisory Committee proceedings to support development of regulatory strategies
Provide risk assessments and recommendations for various regulatory scenarios
Participate in the electronic review and quality verification of regulatory submissions
Manage regulatory data and information within systems
Qualification
Required
Bachelor's degree required; scientific discipline
Experience in Oncology within a biotech/pharma company
Regulatory strategy experience with increasing responsibility
Demonstrated understanding and strategic application of regulations and guidelines for drug development at IND and NDA/BLA stages
Excellent verbal and written communication skills
Leadership ability within a multiple time zone team environment
Ability to work with limited supervision, to set priorities to meet timelines and to motivate and influence others
Exceptional interpersonal skills with the ability to work individually, within a multi-disciplinary team, as well as with external partners and regulators
Some travel will be required
Preferred
Advanced degree is also preferred
Benefits
Discretionary annual cash bonus or incentive compensation
Discretionary equity grants
Medical, dental and vision insurance
401k retirement savings plan
Flexible paid vacation
Company
Jazz Pharmaceuticals
Jazz Pharmaceuticals is a specialty pharmaceutical company that identifies, develops and commercializes innovative treatments.
Founded in 2003
1001-5000 employees
H1B Sponsorship
Jazz Pharmaceuticals 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 (26)
2024 (24)
2023 (25)
2022 (31)
2021 (21)
2020 (39)
Funding
Current Stage
Public CompanyTotal Funding
$2.81BKey Investors
Longitude CapitalKohlberg Kravis Roberts
2024-09-03Post Ipo Debt· $850M
2021-04-22Post Ipo Debt· $1.5B
2009-12-07Post Ipo Debt· $120M
Leadership Team
Renée Galá
President and Chief Executive Officer
Dennis Engelke
Executive Director, Country Manager Switzerland & Austria
Recent News
2026-01-16
Pharmaceutical Technology
2026-01-16
Company data provided by crunchbase