Senior Director, CMC Regulatory Affairs (Cell Therapy)

US Diversity Job Search; Boston (MA); On-site; USD 202,000 - 237,000; Full time

Benefits offered by this job

Health insurance

401(k) plan

Bonuses or commissions

Job summary

Miltenyi Biotec seeks a seasoned Director of Regulatory Affairs (CMC focus) to lead CMC regulatory activities for cell therapy programs in the US, Canada, and other regions. You will partner with Bioindustry and Biotec teams to craft strategies supporting clinical trials, health authority interactions, and product approvals.

Responsibilities include leading CMC submissions, providing regulatory input on process changes, and ensuring readiness for regulatory interactions and marketing

Qualifications

• Bachelor’s degree in life sciences required; advanced degree preferred.
• Experience with CMC regulatory submissions and health authority interactions.
• Knowledge of GMPs and ICH region requirements for pharma/biologics.

Responsibilities

• Develop and implement CMC regulatory strategies for clinical development and post-approval lifecycle.
• Provide strategic regulatory guidance to cross-functional teams.
• Lead preparation and review of CMC sections for INDs, CTAs, BLAs, MAAs.

Skills

Regulatory strategy

Cross-functional guidance

CMC regulatory writing

Regulatory submissions

GMP knowledge

Education

Bachelor's degree in life sciences

Advanced degree in health sciences preferred

Job description

Miltenyi Biotec seeks a seasoned Director of Regulatory Affairs (CMC focus) to lead CMC regulatory activities for cell therapy programs in the US, Canada, and other regions. You will partner with Bioindustry and Biotec teams to craft strategies supporting clinical trials, health authority interactions, and product approvals.

Responsibilities include leading CMC submissions, providing regulatory input on process changes, and ensuring readiness for regulatory interactions and marketing