Associate Manager, Regulatory Affairs Strategy - Oncology

Regeneron Pharmaceuticals•Tarrytown, GA

1d•$109,900 - $179,300•Hybrid

About The Position

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 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.

Requirements

Minimum Bachelors Degree (Advanced degree strongly preferred)
2-3 years of pharmaceutical industry experience in regulatory affairs; 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

Nice To Haves

Experience interacting with CROs in the management of ex-US/ex-EU CTAs towards clinical trial activations

Responsibilities

Coordinating the preparation, submission, management and maintenance of global regulatory submissions related to clinical and nonclinical aspects of product development in oncology therapeutic area, including, but not limited to, the following: 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, collaborates with subject matter experts to provide written responses to queries, provides periodic status updates regarding conditions/commitments
Providing representation for study-level regulatory activities and participate 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 up to current date, comments on draft regulatory guidance, and communicates changes in regulatory information as needed
Exercising discretion and independent judgment in the performance of the duties described above