Regeneron

Director, Regulatory Affairs Strategy – Oncology

Regeneron

full-time

Posted on:

Location Type: Hybrid

Location: Warren • Massachusetts • New Jersey • United States

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Salary

💰 $205,000 - $341,600 per year

Job Level

Lead

About the role

  • provide leadership on global regulatory activities for assigned products
  • focus on clinical regulatory filings
  • provide regulatory leadership on project teams
  • supply, lead and/or supervise IND/CTA and BLA submissions
  • interpret regulatory authorities’ feedback, policies, and guidelines
  • develop regulatory strategic plans with project teams
  • own preparation of major clinical submissions for regulatory approval
  • resolve complex project issues
  • ensure quality and timeliness of IND/CTA and BLA submissions
  • interact with functions and partners in preparation, review, and completion of documents
  • assure compliance with regulations and project team timelines
  • provide interpersonal support and lead personnel
  • critical thinking, strong negotiation and project management skills

Requirements

  • MD, Ph.D. or Pharm D. degree
  • minimum of 10 years of pharmaceutical industry experience
  • at least 7 years of regulatory experience
  • strong understanding of US FDA and international pharmaceutical guidance
  • ability to coordinate and prioritize assigned projects according to company goals
  • interacting with CROs in managing ex-US/ex-EU CTAs towards clinical trial activations preferred
  • 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)
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
IND submissionsCTA submissionsBLA submissionsregulatory strategic planningclinical regulatory filingsregulatory complianceproject management
Soft Skills
leadershipinterpersonal supportcritical thinkingnegotiationcommunication
Certifications
MDPh.D.Pharm D.