About this Associate Director / Director, Regulatory Affairs CMC role at Immunome, Inc.
Company Overview
Position Overview
Immunome is seeking an Associate Director / Director, Regulatory Affairs CMC, responsible for developing and executing global regulatory CMC strategies across multiple modalities. This individual will manage key deliverables and ensure adherence to accelerated regulatory submission schedules. Reporting into the Senior Director, Regulatory Affairs CMC, the role is responsible for communications and interactions with global regulatory authorities. This person will collaborate cross-functionally with teams including Technical Operations, Quality Assurance, Supply Chain Management, and Project Management to maintain alignment with regulatory CMC strategies and compliance requirements.
Responsibilities
- Develop and execute global regulatory CMC strategies across clinical and commercial stages.
- Serve as the regulatory CMC lead on cross-functional teams, providing strategic input to technical operations, supply chain, quality and project teams.
- Author, review and manage the preparation of high-quality CMC sections for regulatory submission (e.g. IND, CTAs, IMPD, annual reports, pediatric plans, amendments, and marketing applications).
- Lead interactions with global health authorities on CMC topics, including preparation of briefing packages, responses to information requests, and representation at meetings.
- Collaborate with internal and external stakeholders to ensure regulatory compliance and alignment with regulatory CMC strategies.
- Maintain current knowledge of regulations and guidelines (e.g., ICH, FDA, EMA) and keep abreast of changes in the global regulatory environment.
- Support regulatory inspections, as required.
Qualifications
- Bachelor’s degree in a relevant scientific discipline required; advanced degree a plus.
- A minimum of 7 years of relevant pharmaceutical/biotechnology industry experience, including 5+ years in regulatory CMC, or equivalent experience.
- Hands-on experience with CMC submission preparation for small molecules, biologics, and/or antibody-drug conjugates.
- Experience with regulatory CMC strategy development and health authority interactions.
Knowledge and Skills
- Deep understanding of ICH, FDA and EMA guidelines.
- Outstanding communication, analytical, organizational and time management skills.
- Strong written and verbal communication abilities with attention to detail.
- Ability to effectively lead cross-functional teams.
- Flexible work style with a pragmatic approach to rapidly changing priorities.
- Proficiency in submission management software, such as Veeva RIM.
Join Our Experienced, Passionate Team
Working at Immunome gives you the opportunity to make a difference in the lives of cancer patients, contribute to developing best-in-class targeted cancer therapies, and work with some of the brightest and most experienced minds in antibody-drug conjugate (ADC) development.
Immunome’s office is charged with the collective excitement and passion of people working together to develop life-changing cancer medicines. Our team thrives in an innovative, collaborative environment where employees are empowered to do their best work.
Immunome also offers a comprehensive benefit program for you and your family, including:
- Medical, dental, and vision insurance coverage for employees and their dependents, including 100% company-paid medical premiums for employees
- A 401(k) with employer match
- Employer-paid life insurance, short- and long-term disability insurance, and AD&D
- Paid time off, company holidays, and a week-long winter break between Christmas and New Years.
- Paid parental leave
E/E/O
Immunome, Inc. is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
E-Verify
Immunome, Inc. is a participant in E-Verify. Please review the following notices: E-Verify Participation Poster | Right to Work Poster (English) | Right to Work Poster (Spanish).
