Regulatory Affairs Director jobs in Washington

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:

• Develop and implement CMC regulatory strategies to support product development, registration, and lifecycle management.
• Lead the preparation, review, and submission of high-quality CMC sections of regulatory filings, including INDs, NDAs, BLAs, MAAs, and post-approval supplements.
• Ensure compliance with global regulatory requirements and guidelines and maintain up-to-date knowledge of current and emerging regulations.
• Provide strategic regulatory guidance to cross-functional product teams.
• Manage CMC interactions with regulatory agencies, including preparation for and participation in meetings and teleconferences.
• Lead the development and execution of risk mitigation strategies for CMC regulatory issues.
• Oversee the preparation and maintenance of CMC regulatory documentation, including regulatory dossiers, technical files, and responses to health authority inquiries.
• Collaborate with external partners and consultants to support CMC regulatory activities and project timelines.
• Provide mentorship and leadership to junior regulatory staff and contribute to the development of the regulatory affairs function within the company.

Requirements

Education and Experience:

• Bachelor’s degree in a relevant technical field (Chemistry, Biochemistry, Pharmaceutical Sciences, or a related field). Advanced degree preferred. Specific regulatory training highly desirable.
• Minimum of 10 years of experience in CMC regulatory affairs within the biotechnology or pharmaceutical industry.

Other Qualifications: 

• Proven track record of successful regulatory submissions, including NDA and/or BLA applications, and interactions with global health authorities, including FDA and EMA.
• In-depth knowledge of global CMC regulatory requirements and guidelines.
• Strong strategic thinking and problem-solving skills.
• Excellent written and verbal communication skills.
• Ability to work effectively in a collaborative, cross-functional team environment.
• Strong leadership skills with experience in managing and developing regulatory affairs teams.
• Detail-oriented with the ability to manage multiple projects and deadlines simultaneously.

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