Lead Regulatory Affairs Strategist

2 weeks ago

Tarrytown, New York, United States Regeneron Pharmaceuticals Full time
Position Overview:

The Lead Regulatory Affairs Strategist will collaborate closely with the Global Regulatory Liaison (GRL) to provide comprehensive support in all facets of regulatory affairs pertinent to the advancement of innovative therapeutics. This includes ensuring adherence to quality standards, as well as navigating preclinical and clinical drug development processes and the associated policies and procedures necessary for regulatory compliance.

Key Responsibilities:

In this capacity, your daily activities may encompass:

  • Overseeing the preparation, submission, management, and upkeep of international regulatory submissions related to both clinical and nonclinical product development. This includes, but is not limited to, INDs/CTAs, amendments, information requests, Orphan drug applications, Annual Reports, and Investigator's Brochure.
  • Assisting in the coordination and preparation for regulatory agency meetings, including the development of relevant briefing documents.
  • Managing and tracking inquiries and commitments with regulatory bodies, collaborating with subject matter experts to formulate written responses, and providing regular updates on conditions and commitments.
  • Representing regulatory activities at the study level and engaging in cross-functional departmental team projects and product development meetings.
  • Conducting research to support the formulation of regulatory strategies for assigned clinical development programs.
  • Maintaining up-to-date knowledge of regulatory requirements, providing feedback on draft regulatory guidance, and communicating necessary changes in regulatory information.
  • Exercising discretion and independent judgment in executing the responsibilities outlined above.
Qualifications:

This role may be suitable for you if:

  • You possess a solid understanding of US FDA and international pharmaceutical regulations, guidance, and the drug development process.
  • You have experience collaborating with CROs in managing international CTAs for clinical trial activations.
  • You demonstrate a keen attention to detail and the ability to prioritize and coordinate projects in alignment with organizational objectives.
  • You exhibit strong interpersonal skills, both written and verbal.

To be considered for this position, you should have excellent communication skills and hold an MD, Ph.D., or Pharm D. degree. A minimum of 5 years of experience in the pharmaceutical industry is expected, with at least 3 years dedicated to regulatory affairs.

Company Culture:
Regeneron Pharmaceuticals is committed to fostering an inclusive and diverse workplace. We offer a comprehensive benefits package that may include health and wellness programs, fitness facilities, equity awards, annual bonuses, and paid time off for eligible employees.

Equal Opportunity Employment:
Regeneron is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, nationality, age, disability, or any other protected characteristic in accordance with applicable laws.

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