Regeneron Pharmaceuticals, Inc

Manager, Regulatory Affairs Strategy - Oncology

Regeneron Pharmaceuticals, Inc • $128K — $210K *
Tarrytown, NY 10591Hybrid
Pharmaceuticals & Biotech
Less than 5 years of experience
Today
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Job Overview by Ladders

Qualifications

  • MD, PhD or PharmD degree required
  • 2+ years of regulatory experience
  • Experience with regulatory filings and document development
  • Knowledge of US FDA and international pharmaceutical guidance
  • Experience managing CTAs with CROs for clinical trials is preferred
  • Strong attention to detail and project management skills
  • Excellent written and verbal communication skills.

Responsibilities

  • Coordinate global regulatory submissions for clinical and nonclinical product development.
  • Assist with preparation for Agency meetings and briefing documents.
  • Lead and track queries with regulatory agencies and provide responses.
  • Represent study-level regulatory activities in cross-functional teams.
  • Maintain and manage regulatory documents and submissions.

Benefits

  • Hybrid work model with 4 days on site per week
  • Opportunity to work in a fast-growing and impactful organization
  • Engage in meaningful work contributing to patient health and wellbeing.
  • Collaborative team environment within Regulatory Affairs.
Full Job Description

Manager, Regulatory Affairs Strategy - Oncology

We are seeking a Manager to join our Regulatory Affairs Strategy Oncology team. The Manager, Regulatory Affairs will report to the Global Regulatory Liaison (GRL) and provides support to the GRL in all aspects of regulatory affairs related to the development of novel therapeutics including quality, preclinical and clinical areas of drug development and the policies/procedures required to ensure compliance with regulations. 

This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

When & where:

  • Work Location: Tarrytown, NY or Warren, NJ

  • Hybrid; 4 days per week on site

Discover your role:

  • 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 

  • 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 

  • Provide representation for study-level regulatory activities and participate in cross-functional departmental team projects and product development activities/meetings 

This role requires:

  • Minimum MD, PhD or PharmD degree along with 2+ years of regulatory experience.

  • We expect to see individuals have worked on filings, helped with developing regulatory related documents and engaged with external partners and authorities. 

  • If you bring good understanding of US FDA and international pharmaceutical guidance, regulations, drug development process, and industry standard practices. 

  • If you are interacting with CROs in the management of ex-US/ex-EU CTAs towards clinical trial activations preferred 

  • If you have a high attention to detail; ability to coordinate and prioritize assigned projects according to company goals 

  • You bring strong interpersonal skills both written and verbally 

Salary Range (annually)

$128,600.00 - $210,000.00

About Regeneron Pharmaceuticals, Inc

Regeneron Pharmaceuticals is a biopharmaceutical company that discovers, develops, and commercializes pharmaceutical products for the treatment of serious medical conditions. The Company has therapeutic candidates in clinical trials for the potential treatment of cancer, eye diseases, and inflammatory diseases, and has preclinical programs in other diseases and disorders. The company’s product portfolio includes EYLEA, an aflibercept injection; ARCALYST, a rilonacept Injection for subcutaneous use; ZALTRAP for metastatic colorectal cancer; trap fusion proteins; and fully human monoclonal antibodies. On March 26, 2012, it was announced that Sanofi and Regeneron are in development with a new cholesterol drug which will help reduce cholesterol up to 72%. Regeneron Pharmaceuticals was founded in 1988 and is currently headquartered in New York, USA.

Regeneron Pharmaceuticals, Inc Careers

Join the innovative team at Regeneron Pharmaceuticals, Inc, a leading biotechnology company renowned for its commitment to science-driven solutions. This is an unparalleled opportunity to advance your career with a company at the forefront of medical breakthroughs and clinical research.

Work You’ll Do

At Regeneron Pharmaceuticals, Inc, you will collaborate with some of the brightest minds in the industry, engaging in work that directly contributes to the health and well-being of populations globally. Our diverse team of professionals is dedicated to pioneering developments in biotechnology through continuous innovation and rigorous research.

Explore Job Opportunities and Growth

Regeneron offers a variety of job opportunities that encourage professional growth and personal achievement. Whether you're seeking an entry-level position or a more senior role, you will find a path that aligns with your career ambitions and skills. Our supportive culture emphasizes leadership development and diversity training, ensuring every team member can thrive.

Internship Programs

Kickstart your career with a Regeneron internship. Our programs provide invaluable industry experience, mentoring from seasoned professionals, and opportunities to develop skills that are crucial in the biotech field. Interns at Regeneron gain hands-on experience, contributing to projects that matter.

Benefits and Culture

Choosing to work at Regeneron Pharmaceuticals, Inc means choosing a career that comes with competitive benefits designed to support you both professionally and personally. We offer comprehensive health benefits, retirement plans, and wellness programs. Our inclusive culture fosters an environment where every employee can flourish, driven by collaboration and mutual respect.

Innovation and Leadership

Lead the way in biotechnological innovation with Regeneron. Our leadership is constantly looking towards the future, investing in cutting-edge technology and research that pave the way for medical advancements. At Regeneron, leadership and innovation go hand in hand, creating a dynamic where breakthroughs are common.

Networking and Professional Development

Enhance your professional network and skill set through Regeneron’s extensive networking opportunities and ongoing professional development programs. We believe in nurturing our talent with advanced training sessions and regular workshops that cover the latest trends and technologies in the biotech industry.

Join Our Team

Discover the impact you can make in a career at Regeneron Pharmaceuticals, Inc. Search for open positions that match your skills and interests. We are continuously hiring and looking for passionate, curious, and innovative team players.

Stay Connected

Keep up to date with the latest at Regeneron by following our careers blog. Gain insights from the experts and learn more about the exciting world of biotech at Regeneron Pharmaceuticals, Inc.

Prepare for Your Interview

Ready to join us? Prepare your resume and refine your interview skills to become part of a company that’s dedicated to changing lives. Personalize your job search and get tailored job alerts directly to your inbox, so you never miss an opportunity to be part of our team. At Regeneron Pharmaceuticals, Inc, your career is poised for tremendous growth and innovation. Explore the opportunities today and be part of a team that’s shaping the future of biotechnology.
Learn more about Regeneron Pharmaceuticals, Inc
Size
10,368 employees
Market Cap
$78.1 billion
Industry
Pharmaceuticals & Biotech
Net Income
$3.5 billion
Founded
1988
5 Year Trend
+27%
Revenue
$8.4 billion
NASDAQ
REGN
* Ladders Estimates

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