Full-Time

Director – Regulatory Affairs Strategy

Oncology

Updated on 3/14/2025

Regeneron Pharmaceuticals

Regeneron Pharmaceuticals

10,001+ employees

Develops medicines for serious diseases

Compensation Overview

$198k - $330kAnnually

Expert

Westchester County, NY, USA + 2 more

More locations: Berkeley Heights, NJ, USA | Tarrytown, NY, USA

This role requires you to work onsite 3 days per week in either Basking Ridge, NJ, Armonk, NY, or Tarrytown, NY.

Category
Risk & Compliance
Legal & Compliance
Requirements
  • Excellent written and verbal communication skills
  • MD, Ph.D. or Pharm D. degree
  • Minimum of 10 years of pharmaceutical industry experience
  • At least 7 years of regulatory experience
Responsibilities
  • Provide leadership on global regulatory activities for assigned products
  • Focus on Clinical Regulatory filings
  • Support clinical study activities
  • Lead and/or supervise IND/CTA and BLA submissions activities
  • Provide interpretation of regulatory authorities’ feedback, policies and guidelines
  • Lead the development of regulatory strategic plans
  • Work with project teams to resolve complex project issues
  • Ensure quality and timeliness of IND/CTA and BLA submissions
  • Interact with other functions and partners in the preparation, review, and completion of documents for regulatory submissions
  • Plan, prioritize, supervise and/or conduct activities in collaboration with leads from other areas
  • Assure compliance with regulations and project team timelines
  • Provide interpersonal support and lead personnel
Desired Qualifications
  • Strong understanding of US FDA and international pharmaceutical guidance, regulations, drug development process, and industry standard practices
  • Experience interacting with CROs in the management of ex-US/ex-EU CTAs towards clinical trial activations
  • High attention to detail; ability to coordinate and prioritize assigned projects according to company goals
  • Strong interpersonal skills both written and verbally
Regeneron Pharmaceuticals

Regeneron Pharmaceuticals

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Regeneron Pharmaceuticals develops medicines aimed at treating serious diseases such as cancer, eye diseases, and allergic conditions. The company uses its own technologies and extensive research to create new therapies, often collaborating with academic institutions and other pharmaceutical companies to enhance its development efforts. Unlike many competitors, Regeneron focuses on both research and commercialization, generating revenue through the sale of its approved medicines and licensing its technologies. The goal of Regeneron is to improve patient outcomes by providing effective treatments and ensuring that its products meet high safety and efficacy standards.

Company Size

10,001+

Company Stage

IPO

Headquarters

Town of Greenburgh, New York

Founded

1988

Simplify Jobs

Simplify's Take

What believers are saying

  • Regeneron's Dupixent shows promise in treating bullous pemphigoid with positive trial results.
  • Increased investments in AI-driven drug discovery could boost Regeneron's R&D capabilities.
  • The rise of personalized medicine aligns with Regeneron's focus on targeted therapies.

What critics are saying

  • Regeneron faces competition from companies like Amgen and AstraZeneca in similar therapeutic areas.
  • Potential regulatory delays, as seen with odronextamab, could impact market timelines.
  • Adverse events in new treatments like Dupixent may affect patient safety perceptions.

What makes Regeneron Pharmaceuticals unique

  • Regeneron excels in developing life-transforming medicines for serious diseases.
  • The company leverages proprietary technologies for innovative drug discovery and development.
  • Strategic partnerships enhance Regeneron's research and development capabilities.

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Benefits

Health Insurance

Wellness Program

Paid Vacation

Equity Awards

Annual Bonuses

Flexible Work Hours

Company News

PR Newswire
Mar 11th, 2025
Regeneron Science Talent Search 2025 Awards More Than $1.8 Million To High School Seniors For Innovative Research On Classifying Celestial Objects, Treating A Rare Muscle Disease And Solving A Long-Standing Math Problem

$250,000 top award goes to Matteo Paz in America's longest running and most distinguished science and math competitionTARRYTOWN, N.Y. and WASHINGTON, March 11, 2025 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. and Society for Science (the Society) announced that Matteo Paz, 18, of Pasadena, California, won the top award of $250,000 in the 2025 Regeneron Science Talent Search, the U.S.'s oldest and most prestigious science and math competition for high school seniors.Congratulations to the top three Regeneron Science Talent Search award winners, Ava Grace Cummings, Matteo Paz and Owen Jianwen Zhang (left to right) Photo Credit: Chris Ayers Photography/Licensed by Society for ScienceNow in its 84th year, the competition celebrates and rewards young innovators who are applying their Science, Technology, Engineering and Math (STEM) talent and leadership skills to push the boundaries of discovery and address today's pressing challenges.Forty finalists, including Matteo, were honored this evening during an award ceremony at the National Building Museum in Washington, D.C, where they were awarded more than $1.8 million in prizes for their groundbreaking research, exceptional problem-solving skills and potential to shape the future of STEM.Matteo Paz , 18, of Pasadena, California , won first place and $250,000 for designing machine-learning algorithms to efficiently comb through 200 billion entries of raw NEOWISE infrared full-sky data. By analyzing tiny changes in infrared radiation, the AI sorted the objects into 10 classes. He found 1.5 million new potential objects.won first place and for designing machine-learning algorithms to efficiently comb through 200 billion entries of raw NEOWISE infrared full-sky data. By analyzing tiny changes in infrared radiation, the AI sorted the objects into 10 classes

MarketBeat
Mar 10th, 2025
American Assets Inc. Makes New $427,000 Investment in Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN)

American Assets Inc. makes new $427,000 investment in Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN).

PharmiWeb
Mar 10th, 2025
Dupixent Late-Breaking Positive Pivotal Data In Bullous Pemphigoid Presented At Aad

Five times more adults on Dupixent achieved sustained disease remission at 36 weeks compared to placebo; significant reductions were also seen in disease severity and itchDupixent also significantly reduced oral corticosteroid and rescue medicine use compared to placeboData support the potential of Dupixent to be the first and only targeted medicine to treat bullous pemphigoid, a skin disease with underlying type 2 inflammation; regulatory submissions are under review in the US and the EUParis and Tarrytown, NY, March 8, 2025. Positive results from the pivotal ADEPT phase 2/3 study evaluating the investigational use of Dupixent (dupilumab) in adults with moderate-to-severe bullous pemphigoid (BP) were shared in a late-breaking oral presentation at the 2025 American Academy of Dermatology (AAD) Annual Meeting. BP is a chronic, debilitating, and relapsing skin disease with underlying type 2 inflammation and characterized by intense itch and blisters, reddening of the skin, and painful lesions.Victoria Werth, MDChief of the Division of Dermatology at the Philadelphia Veterans Administration Hospital, Professor of Dermatology and Medicine at the Hospital of the University of Pennsylvania and the Veteran's Administration Medical Center, and principal investigator of the study“People with bullous pemphigoid live with unrelenting itch, blisters, and painful lesions that can be debilitating and make it difficult to function daily. Moreover, current treatment options can be challenging for this primarily elderly patient population because they work by suppressing their immune system. By targeting the underlying type 2 inflammation, which is a key driver for bullous pemphigoid, Dupixent is the first investigational biologic to show sustained disease remission and reduce disease severity and itch compared to placebo in a clinical study.”The ADEPT study met all primary and key secondary endpoints, enrolling 106 adults with moderate-to-severe BP who were randomized to receive Dupixent 300 mg (n=53) every two weeks after an initial loading dose or placebo (n=53) added to standard-of-care oral corticosteroids (OCS). During treatment, all patients underwent a protocol-defined OCS tapering regimen if control of disease activity was maintained

PR Newswire
Mar 1st, 2025
Positive Results From Tezspire® (Tezepelumab-Ekko) Phase 3 Waypoint Trial Highlight Rapid, Sustained Effect In Chronic Rhinosinusitis With Nasal Polyps

Significantly Reduced Nasal Congestion, Polyp Size and Nearly Eliminated Need for Surgery. Data Published in NEJM and Presented at AAAAI/WAO 2025. THOUSAND OAKS, Calif., March 1, 2025 /PRNewswire/ -- Amgen (NASDAQ:AMGN) and AstraZeneca today announced full results from the Phase 3, registrational WAYPOINT trial demonstrating that TEZSPIRE® (tezepelumab-ekko) significantly reduced nasal polyp severity, the need for surgery and systemic corticosteroid use in patients with chronic rhinosinusitis with nasal polyps (CRSwNP [nasal polyps]) compared to placebo.1,2 The data were published today in the New England Journal of Medicine and were highlighted as a late-breaking oral presentation during the American Academy of Allergy Asthma Immunology (AAAAI)/World Allergy Organization (WAO) Joint Congress in San Diego.1,2

RegMedNet
Feb 27th, 2025
Cell therapy weekly: world's first hospital-based autologous foundry

At the Research in Otolaryngology's 48th Annual MidWinter Meeting (22 - 26 February 2025; Orlando, FL), Regeneron Pharmaceuticals provided an update on the Phase I/II CHORD trial for DB-OTO, an investigational gene therapy for congenital hearing loss due to OTOF gene variants.