CMC Documentation Specialist

Job Title : CMC Documentation Specialist

Location : San Rafael, CA (Hybrid / Onsite as required)

Duration : 12+ months contract

Experience : 8+ years

Job Overview :

We are seeking an experienced CMC Documentation Specialist to join our team in San Rafael, CA. The ideal candidate will have a strong background in authoring and managing complex CMC (Chemistry, Manufacturing, and Controls) documentation for regulatory submissions. This role requires precision, strong scientific literacy, and the ability to clearly convey complex information to internal teams and regulatory authorities. The Technical Writer will play a pivotal role in ensuring that submission dossiers are accurate, complete, and ready for health authority review.

Key Responsibilities :

Author, review, and finalize CMC-related documents for regulatory submissions.

Initiate and manage document reviews with internal stakeholders and cross-functional teams.

Lead comment adjudication and resolve conflicting feedback to finalize content.

Ensure all documentation meets regulatory standards and submission requirements.

Collaborate with scientists, regulatory affairs professionals, and project teams to ensure accurate technical content.

Maintain version control and ensure timely delivery of submission-ready dossiers.

Interpret complex scientific and technical information and translate it into clear, concise, and accurate written content.

Required Skills :

Excellent written and verbal communication skills.

Strong ability to understand, analyze, and interpret complex scientific and technical information.

Experience with CMC documentation and regulatory submissions.

Attention to detail and commitment to high-quality deliverables.

Ability to work independently and manage multiple projects simultaneously.

Strong organizational and time-management skills.

Proficiency in document management systems and Microsoft Office Suite.

Experience collaborating with cross-functional teams in a fast-paced environment.

Preferred Qualifications :

Experience with electronic submission platforms (eCTD, eSub).

Background in biotechnology, pharmaceuticals, or life sciences.

Familiarity with regulatory guidelines (FDA, EMA, ICH).