Overview

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking an Associate Manager to join our Regulatory Affairs Strategy (Oncology) team.

The Associate Manager, Regulatory Affairs will report to the Global Regulatory Liaison (GRL) and provides support 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.

Work Location

• •Tarrytown, NY or Warren, NJ
• •4 days per week on site

Responsibilities

• •Coordinating the preparation, submission, management and maintenance of global regulatory submissions related to clinical and nonclinical aspects of product development in oncology, including INDs/CTAs, amendments and information requests, Orphan drug applications, Annual Reports and Investigator's Brochure
• •Assisting in coordination and preparation for Agency meetings and associated briefing document preparation
• •Managing and tracking queries and commitments with regulatory agencies, collaborating with subject matter experts to provide written responses to queries, and providing periodic status updates regarding conditions/commitments
• •Providing representation for study-level regulatory activities and participating in cross-functional departmental team projects and product development activities/meetings
• •Performing research to support the development of regulatory strategy for the assigned clinical development program
• •Maintaining knowledge of regulatory requirements, commenting on draft regulatory guidance, and communicating changes in regulatory information as needed
• •Exercising discretion and independent judgment in the performance of assigned duties

Requirements

• •Minimum MD, PhD, or PharmD degree along with relevant internship, fellowship, post-doc experience, or industry experience
• •Experience in oncology preferred
• •Knowledgeable 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 preferred
• •High attention to detail; ability to organize and prioritize assigned projects according to corporate goals
• •Ability to work in close collaboration with colleagues in regulatory department and throughout the development organization
• •Proficient in written, oral, and interpersonal communications in English

Compensation

Salary Range: $109,900 - $179,300 annually. Regeneron offers a competitive and comprehensive total rewards package which may include annual bonuses or other incentive plans, equity awards, retirement benefits, 401(k) company match, health and wellness programs, insurance benefits, paid time off, and family support benefits.