Manager, Regulatory Affairs Strategy – Oncology

Regeneron

Manager, Regulatory Affairs managing global regulatory submissions for Oncology team at Regeneron. Collaborating with cross-functional teams to ensure compliance with drug development regulations in a fast-growing environment.

Posted 7/20/2026full-timeTarrytown • New Jersey, New York • 🇺🇸 United StatesJuniorMid-Level💰 $128,600 - $210,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in global regulatory submissions and compliance, with a strong understanding of US FDA and international pharmaceutical guidance. Proven ability to collaborate with cross-functional teams and engage with regulatory agencies effectively.

Highest-signal resume keywords

Regulatory Submissions ManagementUS FDA Guidance KnowledgeRegulatory Document DevelopmentInterpersonal Communication SkillsRegulatory Experience

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory SubmissionsRegulatory Document PreparationFilingsDrug Development ProcessRegulatory Compliance

Soft Skills

Attention to DetailWritten CommunicationVerbal Communication

Certifications & Qualifications

MDPhDPharmD

Industry Keywords

Regulatory AgenciesCross-Functional CollaborationAgency MeetingsExternal PartnersPharmaceutical Guidance

About the role

Key responsibilities & impact

Coordinate the preparation, submission, management and maintenance of global regulatory submissions
Assist in coordination and preparation for Agency meetings and associated briefing document preparation
Leads 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
Provides representation for study-level regulatory activities
Participates in cross-functional departmental team projects and product development activities/meetings

Requirements

What you’ll need

Minimum MD, PhD or PharmD degree
2+ years of regulatory experience
Worked on filings
Helped with developing regulatory related documents
Engaged with external partners and authorities
Good understanding of US FDA and international pharmaceutical guidance
Regulations and drug development process
High attention to detail
Strong interpersonal skills both written and verbally

Benefits

Comp & perks

annual bonuses or other incentive plans
equity awards
pension or retirement benefits
401(k) company match
health and wellness programs
fitness centers
insurance benefits (e.g. medical, dental, vision, life and disability)
paid time off
family support benefits