Senior Director, Regulatory Affairs CMC – Biologics (Biotechnology)

Location: Hybrid in Boston, Massachusetts, US, with at least two on-site days per week, currently Tuesday and Wednesday. Additional on-site attendance may be required based on business needs.

Salary: $242,000–$313,500 USD annually, plus a discretionary annual bonus and potential long-term incentive award.

Company

hirify.global is a clinical-stage biotechnology company developing precision therapies for autoimmune and inflammatory diseases.

What you will do

• Develop and lead biologics CMC regulatory strategies across the I&I portfolio from IND/CTA through BLA, MAA, and post-approval lifecycle management.
• Author, review, and oversee biologics CMC sections of global ICH CTD/eCTD submissions, including supplements and post-approval variations.
• Lead FDA and EMA interactions, including Type B, Type C, BPD, and Scientific Advice meetings, as well as responses to deficiency letters and information requests.
• Partner with Process Development, Analytical Sciences, Manufacturing Sciences, Formulation, Quality, Drug Supply, and external biologics CMOs.
• Guide process characterization, comparability, control strategy, technology transfer, site changes, analytical updates, and biologics manufacturing validation.
• Track regulatory deliverables, submission timelines, risks, and dependencies while helping build the company’s biologics CMC regulatory infrastructure.

Requirements

• Advanced degree in biochemistry, molecular biology, pharmaceutical sciences, immunology, or a related biologics discipline, or equivalent experience.
• At least 12 years of CMC regulatory affairs experience in the pharmaceutical or biotechnology industry.
• Deep expertise in biologics CMC strategy, including cell line development, upstream and downstream process development, validation, characterization, analytical methods, formulation, and fill-finish.
• Extensive experience with INDs/CTAs, BLAs, MAAs, supplements, variations, and ICH CTD/eCTD submissions.
• Experience leading FDA and EMA biologics CMC meetings and managing deficiency letter responses.
• Strong knowledge of ICH Q8, Q9, Q10, Q11, Q12, and Q13, FDA biologics CMC guidance, and EMA quality guidance.

Culture & Benefits

• Entrepreneurial, resourceful environment with ownership, accountability, inclusion, and continuous learning.
• Opportunity to shape biologics CMC regulatory capabilities in a clinical-stage biotechnology company.
• Health and wellness coverage tailored to the country and region of hire.
• Paid time off, public holidays, and additional leave according to local requirements.
• Flexible work arrangements with a hybrid schedule.