Associate Manager Regulatory Affairs
The Associate Manager, Regulatory Affairs will report to the Global Regulatory Liaison (GRL) and provides support to the GRL in all aspects 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 will be located in our Tarrytown office.In this role, a typical day might include the following:
Coordinate 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.
Assist in coordination and preparation for Agency meetings and associated briefing document preparation.
Manages and supervises queries and commitments with regulatory agencies, collaborates with SME's 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.
Perform research to support the creation regulatory strategy for the assigned clinical development program.
Maintains knowledge of regulatory requirements up to current date, comments on draft regulatory guidance, and communicates changes in regulatory information as needed.This role might be for you if:
Advanced Scientific degree required.
2-3 years of pharmaceutical industry experience in regulatory affairs; experience in oncology preferred
Knowledge of US FDA and international pharmaceutical requirements, regulations, drug development process, and industry practices.
Experience interacting with CROs in the management of ex-US CTAs towards clinical trial activations preferred
High attention to detail; ability to coordinate and prioritize assigned projects.
Ability to work in close collaboration with colleagues in regulatory department and throughout the development organization.
Proficient in written, oral, and interpersonal communication skills.