Associate Director / Director, Regulatory Affairs CMC

The role

This person will develop and execute global regulatory CMC strategies across multiple modalities. They will manage key deliverables, lead interactions with global health authorities, and collaborate cross-functionally to ensure compliance.

What you will do

• Develop and execute global regulatory CMC strategies across clinical and commercial stages.
• Serve as the regulatory CMC lead on cross-functional teams.
• Author, review and manage the preparation of high-quality CMC sections for regulatory submission.
• Lead interactions with global health authorities on CMC topics.
• Collaborate with internal and external stakeholders to ensure regulatory compliance.
• Maintain current knowledge of regulations and guidelines.
• Support regulatory inspections, as required.

Required qualifications

• Bachelor’s degree in a relevant scientific discipline
• 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
• 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

Nice to have

• advanced degree

Benefits

• Medical, dental, and vision insurance coverage for employees and their dependents
• 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
• a week-long winter break between Christmas and New Years
• Paid parental leave

About the company

Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted cancer therapies. The company is advancing an innovative portfolio of therapeutics, including antibody-drug conjugates.