Regeneron · 23 hours ago
Senior Manager, Regulatory Affairs Strategy - Oncology
Tarrytown, NY
Full-time
Onsite
Senior Level
$148K/yr - $242K/yr
5+ years expRegeneron is a biotechnology company focused on developing novel therapeutics. The Senior Manager, Regulatory Affairs will support the Global Regulatory Liaison in regulatory affairs related to drug development, including managing global regulatory submissions and coordinating with regulatory agencies.
BiopharmaBiotechnologyPharmaceutical
Responsibilities
Coordinate the preparation, submission, management and maintenance of global regulatory submissions related to clinical and nonclinical aspects of product development, including, but not limited to, the following: INDs/CTAs, amendments and information requests, Orphan drug applications, Annual Reports and Investigator’s Brochure
Assist in coordination and preparation for Agency meetings and associated briefing document preparation
Manages and tracks queries and commitments with regulatory agencies, collaborates with subject matter experts to provide written responses to queries, provides periodic status updates regarding conditions/commitments
Provide representation for study-level regulatory activities and participate in cross-functional departmental team projects and product development activities/meetings
Perform research to support the development of regulatory strategy for the assigned clinical development program
Maintains knowledge of regulatory requirements up to current date, comments on draft regulatory guidance, and communicates changes in regulatory information as needed
Exercise discretion and independent judgment in the performance of the duties described above
Qualification
Required
Excellent written and verbal communication skills
MD, Ph.D. or Pharm D. degree
Minimum of 5 years of pharmaceutical industry experience, at least 3 of which should include regulatory experience
Preferred
Good understanding of US FDA and international pharmaceutical guidance, regulations, drug development process, and industry standard practices
Interacting with CROs in the management of ex-US/ex-EU CTAs towards clinical trial activations preferred
High attention to detail; ability to coordinate and prioritize assigned projects according to company goals
Strong interpersonal skills both written and verbally
Benefits
Health and wellness programs (including medical, dental, vision, life, and disability insurance)
Fitness centers
401(k) company match
Family support benefits
Equity awards
Annual bonuses
Paid time off
Paid leaves (e.g., military and parental leave)
Company
Regeneron
Regeneron Pharmaceuticals specializes in the discovery, development, and commercialization of innovative medicines.
10001+ employees
H1B Sponsorship
Regeneron 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 (157)
2024 (128)
2023 (128)
2022 (137)
2021 (104)
2020 (122)
Funding
Current Stage
Public CompanyTotal Funding
$15.93MKey Investors
U.S. Department of Health & Human Services
2024-07-11Post Ipo Equity· $2.03M
2023-10-18Post Ipo Equity· $5M
2016-08-22Post Ipo Equity· $8.9M
Leadership Team
Aris Baras
Senior Vice President, Regeneron Pharmaceuticals, General Manager, Regeneron Genetics Center
Bari Kowal
Senior Vice President, Head Development Operations & Portfolio Management
Recent News
Pharmaceutical Technology
2026-01-16
2026-01-16
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