Onsite CMC Regulatory Dossier Manager – 1-Year Contract

System One Clinical & Science; Alameda (CA); On-site; USD 90,000 - 120,000; Full time

Job summary

System One Clinical & Science in Alameda, CA seeks a CMC Regulatory Dossier Management consultant for a one-year renewable contract on-site. You will coordinate authoring, review, and approval of CMC regulatory documents.

The role requires experience with regulatory information management systems (RIM) such as Veeva, CTD templates, and global regulatory submissions. Strong timelines, document control, and cross‑functional collaboration with external partners are essential.

Qualifications

• BA/BS with 2–4 years of medical/technical writing experience.
• MS with 1 year in technical (CMC) or regulatory writing.
• Minimum 5 years in pharmaceutical or biotech industries.
• CMC knowledge with support of manufacturing ops.
• Familiarity with CTD templates and regulatory content.

Responsibilities

• Manage authoring, review, and approval of CMC regulatory docs.
• Coordinate document reviews and schedule meetings.
• QC regulatory docs with SMEs and archive source docs.
• Support domestic and global lifecycle submissions with partners.
• Maintain procedures, templates, and working practices.

Skills

Regulatory writing

Document management

CMC knowledge

Regulatory submissions

Stakeholder communication

Education

BA/BS in related field

MS in related field

Tools

Veeva

Job description

System One Clinical & Science in Alameda, CA seeks a CMC Regulatory Dossier Management consultant for a one-year renewable contract on-site. You will coordinate authoring, review, and approval of CMC regulatory documents.

The role requires experience with regulatory information management systems (RIM) such as Veeva, CTD templates, and global regulatory submissions. Strong timelines, document control, and cross‑functional collaboration with external partners are essential.