Regulatory Affairs Director oversees regulatory matters and executes the strategy to ensure the organization complies with applicable regulations. Develops processes and systems to ensure that all necessary licensing, filings, certifications, and permits are processed and monitored. Being a Regulatory Affairs Director establishes monitoring policies and procedures to ensure compliance with existing regulations. Anticipates new or changing regulations and coordinates with internal stakeholders to develop strategies to address changes in product, operations, or testing requirements. Additionally, Regulatory Affairs Director investigates and addresses any reported issues of non-compliance. Requires a bachelor's degree. Typically reports to a director. The Regulatory Affairs Director typically manages through subordinate managers and professionals in larger groups of moderate complexity. Provides input to strategic decisions that affect the functional area of responsibility. May give input into developing the budget. To be a Regulatory Affairs Director typically requires 3+ years of managerial experience. Capable of resolving escalated issues arising from operations and requiring coordination with other departments. (Copyright 2024 Salary.com)
Description
Job Title: Director Regulatory Affairs, CMC
Location: Bothell
About Us:
Immunome is a clinical stage biotechnology company headquartered in Bothell, WA dedicated to developing first-in-class and best-in-class targeted cancer therapies. Our portfolio pursues each target with a modality appropriate to its biology, including immunotherapies, targeted effectors, radioligand therapies and antibody drug conjugates (ADCs). We believe that pursuing underexplored targets with appropriate drug modalities leads to transformative therapies. Our proprietary memory B cell hybridoma technology allows for the rapid screening and functional characterization of novel antibodies and targets.
Position Overview:
We are seeking a highly experienced and strategic CMC Regulatory Affairs professional to join our growing team. This position will report to the head of Regulatory. The successful candidate will be responsible for leading all CMC regulatory activities from IND filing to post-marketing commitments, ensuring compliance with global regulatory requirements, and supporting the development and commercialization of our pipeline products. This role requires a deep understanding of CMC regulatory requirements, strong leadership skills, and the ability to work effectively in a fast-paced, collaborative environment.
Key Responsibilities:
Requirements
Education and Experience:
Other Qualifications:
E/E/O
Immunome, Inc. is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
Salary Range
$212,000 - $231,000