CMC Regulatory Manager - Onsite Alameda

ACTalent; Alameda (CA); On-site; USD 103,000 - 124,000; Full time

Benefits offered by this job

Medical, dental & vision

401(k) retirement plan

Paid time off

Job summary

Actalent is seeking a Regulatory CMC Manager in Alameda, CA to lead authoring, review, and approval of regulatory documents and oversee the document lifecycle for domestic and global submissions.

The role requires 3–5 years in a technical CMC field within pharma/biotech, strong regulatory writing, and cross-functional collaboration. Onsite work in Alameda, CA with a contract arrangement and competitive hourly pay.

Qualifications

• 3–5 years in a technical CMC field within pharma/biotech.
• Experience in analytical chemistry, QC testing, manufacturing operations, quality, and biomanufacturing.
• Proficiency in regulatory writing including SOPs and regulatory documents.
• Cross-functional experience with strong communication skills.
• Detail-oriented with document and system management experience.
• Proficient in advanced Word features and using style sheets.

Responsibilities

• Support the development of high-quality, phase-appropriate CMC submissions to health authorities.
• Manage authoring, review, and approval of regulatory documents.
• Oversee the document review process and schedule meetings to ensure timelines.
• Provide status updates to stakeholders as necessary.
• Manage QC checks of regulatory documentation by technical SMEs and archive source docs.
• Facilitate domestic and global regulatory submissions with external partners and vendors.
• Ensure regulatory compliance and risk-based approaches to manufacturing flexibility while adhering to change control and health authority requirements.
• Contribute to the development and maintenance of procedures, templates, and documents.

Skills

CMC knowledge

Analytical chemistry

Regulatory writing

Cross-functional comms

Document management

Word advanced functions

Tools

RIM systems

Documentum

Job description

Actalent is seeking a Regulatory CMC Manager in Alameda, CA to lead authoring, review, and approval of regulatory documents and oversee the document lifecycle for domestic and global submissions.

The role requires 3–5 years in a technical CMC field within pharma/biotech, strong regulatory writing, and cross-functional collaboration. Onsite work in Alameda, CA with a contract arrangement and competitive hourly pay.