Regulatory CMC Associate Manager – Global Strategy

Biopharma Careers; Billerica (MA); Hybrid; USD 78,000 - 117,000; Full time

Benefits offered by this job

Health insurance

PTO

Retirement contributions

Job summary

MilliporeSigma in the United States is seeking an Associate Manager Regulatory CMC to support all CMC regulatory activities, own the CMC dossier strategy, and lead dossier content decisions for worldwide submissions. Hybrid work in Billerica, MA, with responsibilities spanning strategy, HA interactions, and dossier generation.

Minimum qualifications include a life sciences bachelor’s and 1+ year regulatory experience; advanced degrees preferred.

Qualifications

• Bachelor’s Degree in a Life Science discipline.
• 1+ years of pharmaceutical industry or academia experience and regulatory or CMC knowledge.

Responsibilities

• Global Regulatory CMC coordination and plan execution.
• Support development of Global Regulatory CMC strategy for development programs.
• Prepare regulatory CMC documentation and submissions (IMPD/IND, HA meetings, variations, amendments).
• Provide regulatory CMC advice in cross-functional teams and liaise with Global Health Operations and R&D.

Skills

Regulatory knowledge

Regulatory strategy development

Education

Bachelor’s degree in life science

Master’s degree or PhD

Job description

MilliporeSigma in the United States is seeking an Associate Manager Regulatory CMC to support all CMC regulatory activities, own the CMC dossier strategy, and lead dossier content decisions for worldwide submissions. Hybrid work in Billerica, MA, with responsibilities spanning strategy, HA interactions, and dossier generation.

Minimum qualifications include a life sciences bachelor’s and 1+ year regulatory experience; advanced degrees preferred.