Regeneron Pharmaceuticals, Inc

Director, Regulatory Affairs Strategy - Genetics Medicine

Regeneron Pharmaceuticals, Inc • $205K — $341K *
Warren, MI 48089In-Person
Pharmaceuticals & Biotech
8 - 10 years of experience
3 weeks ago
Job Overview by Ladders

Qualifications

  • MD, Ph.D., Pharm.D., or equivalent advanced degree in a relevant scientific discipline.
  • 10+ years of experience in pharmaceutical or biotechnology industry.
  • 7+ years of experience specifically in regulatory affairs.
  • Demonstrated success leading regulatory strategy and global health authority interactions.
  • Strong understanding of US FDA and international regulations and drug development processes.

Responsibilities

  • Provide regulatory authority feedback interpretation and strategic implications to teams.
  • Lead development and maintenance of regulatory strategic plans and major clinical submissions.
  • Resolve complex regulatory issues with cross-functional teams leveraging global regulations expertise.
  • Ensure quality and timeliness of IND/CTA/BLA submissions through collaboration with partners.
  • Lead health authority interactions and advise stakeholders on feedback.
  • Represent regulatory affairs in senior program meetings, providing strategic input.
  • Mentor and develop regulatory staff while supporting their career growth.

Benefits

  • Hybrid work model with 4 days onsite per week.
  • Relocation support available for qualified candidates.
  • Opportunity to contribute to impactful genetics medicine initiatives.
Full Job Description

Director, Regulatory Affairs Strategy - Genetics Medicine

The Director, Regulatory Affairs Strategy will provide leadership on global regulatory activities for assigned products within the Genetic Medicine portfolio. This role is focused on regulatory strategy and filings, with responsibility for providing regulatory leadership across project teams. Consistent with our hands-on culture, the Director will be actively involved in clinical study support and will lead IND/CTA and BLA submission activities.

The Director will develop and maintain regulatory strategy at the study, indication, and program level, lead interactions with global health authorities, and serve as a key cross-functional partner and subject matter expert. This role also carries people management responsibility, including mentoring and developing regulatory staff.

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:

  • Providing interpretation of regulatory authority feedback, policies, and guidelines, and communicating strategic implications to project teams and senior management.

  • Leading the development and maintenance of regulatory strategic plans, either directly in conjunction with project teams or through direct reports. Owning the preparation of major clinical submissions required for regulatory approvals.

  • Working with cross-functional project teams to resolve complex regulatory issues, utilizing deep expertise in global regulations and guidances to strategically plan and communicate requirements.

  • Ensuring the quality and timeliness of regulatory submissions for IND/CTA/BLA; collaborating with other functions and partners in the preparation, review, and completion of submission documents.

  • Leading health authority interactions, including preparation of briefing books and meeting slides, and advising relevant stakeholders on agency feedback.

  • Representing regulatory affairs at senior program team meetings, providing strategic input and direction as a subject matter expert.

  • Planning, prioritizing, and overseeing regulatory activities in close collaboration with leads from other functions to ensure compliance and alignment with project timelines.

  • Mentoring and developing regulatory staff, providing direction and supporting career growth.

  • You bring a strong understanding of US FDA and international pharmaceutical guidance, regulations, drug development processes, and industry standard practices.

  • You have demonstrated success leading regulatory strategy and health authority interactions across global programs, with the ability to influence cross-functional teams and senior leadership.

  • You are comfortable operating in ambiguous, fast-paced environments and can manage multiple programs and priorities simultaneously.

  • You have experience managing or interacting with CROs in the management of ex-US/ex-EU CTAs toward clinical trial activations.

  • You bring strong interpersonal and communication skills, both written and verbal, with the ability to produce persuasive and high-quality regulatory documents.

This role requires:

  • An MD, Ph.D., Pharm.D., or equivalent advanced degree; a relevant scientific discipline is strongly preferred.

  • A minimum of 10 years of pharmaceutical or biotechnology industry experience, with at least 7 years in regulatory affairs, including direct experience as a regulatory liaison.

  • This role requires onsite presence 4 days per week in Tarrytown, NY or Warren, NJ. Relocation support is available for qualified candidates.

Salary Range (annually)

$205,000.00 - $341,600.00

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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