Regulatory Affairs Intern
EntryRegulatory AffairsOncology
Market Rate — Natural Sciences Managers
25th
$120K
Median
$158K
75th
$205K
BLS 2024 data (national)
Description
<div class="content-intro"><p style="line-height: 1.2;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell, T-cell receptor (TCR-T), and natural killer (NK) cell-based immunotherapy. From our three R&amp;D sites around the world, we apply these innovative technologies to pursue the discovery of safe, efficacious and cutting-edge therapeutics for patients worldwide.</span></p>
<p style="line-height: 1.2;">&nbsp;</p>
<p style="line-height: 1.2;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson &amp; Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta-cel). Our strategic partnership is designed to combine the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma.</span></p>
<p style="line-height: 1.2;">&nbsp;</p></div><p><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Legend Biotech is seeking an <strong>Regulatory Affairs Intern </strong>as part of the <strong>Regulatory Affairs </strong>team based in <strong>Somerset, NJ</strong>.</span></p>
<p><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><strong>Role Overview</strong></span></p>
<p><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">The Regulatory Affairs Intern will support the Regulatory team in planning and executing regulatory strategies, submissions, and compliance activities across pipeline programs.</span></p>
<p><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">This internship is designed for MS or Doctoral candidates pursuing careers in regulatory science, biotechnology, pharmacy, life sciences, or related fields.</span></p>
<p><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><strong>Key Responsibilities</strong></span></p>
<ul>
<li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Support regulatory intelligence and conduct research and analysis on regulatory guidelines and requirements</span></li>
<li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Develop and lead a short-term project aligned such as authoring a regulatory white paper, researching and presenting on a regulatory topic, or supporting execution of a regulatory submission.</span></li>
<li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Assist with preparation, formatting, and quality checks of regulatory submissions to health authorities</span></li>
<li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Participate in internal meetings with regulatory, clinical, CMC, quality, and project teams to support alignment and decision-making</span></li>
<li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Help maintain and organize regulatory documentation, registries, and tracking systems.&nbsp;</span></li>
</ul>
<p class="col-xs-12 no-horiz-padding"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><strong>Requirements</strong></span></p>
<ul>
<li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Desired Academic Grade Level: MS or Doctorate (e.g. PharmaD, MD, PhD) candidates.&nbsp;</span></li>
</ul>
<p class="col-xs-12 no-horiz-padding"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">#Li-JR1</span></p>
<p class="col-xs-12 no-horiz-padding"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">#Li-Contract</span></p><div class="content-conclusion"><p><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><strong>Please note: These benefits are offered exclusively to permanent full-time employees. Contractors are not eligible for benefits through Legend Biotech.</strong></span></p>
<p>&nbsp;</p>
<p style="line-height: 1.2;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><strong>EEO Statement</strong></span></p>
<p style="line-height: 1.2;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">It is the policy of Legend Biotech to provide equal employment opportunities without regard to actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, related medical conditions and lactation), gender identity or gender expression (including transgender status), sexual orientation, marital status, military service and veteran status, disability, genetic information, or any other protected characteristic under applicable federal, state or local laws or ordinances.</span></p>
<p style="line-height: 1.2;">&nbsp;</p>
<p style="line-height: 1.2;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Employment is at-will and may be terminated at any time with or without cause or notice by the employee or the company.</span></p>
<div>&nbsp;</div>
<div><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">For information related to our privacy policy, please review:&nbsp;<a href="https://legendbiotech.com/privacy-policy-2/" target="_blank">Legend Biotech Privacy Policy.</a></span></div></div>
Legend Biotech
BIOTECHNOLOGY
Cell Therapy
LocationNJ - Piscataway
Open Jobs106
Gene TherapyCell Therapy
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