Regulatory CMC Manager

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

Job Title: Regulatory CMC ManagerJob Description

We are seeking a dedicated and skilled Regulatory CMC Manager to support the development of high-quality, phase-appropriate CMC-related submissions to health authorities. This role involves managing the authoring, review, and approval of regulatory documents, as well as overseeing the document review process to ensure timelines are met. The successful candidate will provide status updates to stakeholders, manage the QC check of regulatory documentation, and facilitate domestic and global regulatory lifecycle submissions.

Responsibilities

• Support the development of high-quality, phase-appropriate CMC-related submissions to health authorities.

• Manage the authoring, review, and approval of regulatory documents.

• Oversee the document review process and schedule meetings to ensure timelines are achieved.

• Provide status updates to stakeholders as necessary.

• Manage the QC check of regulatory documentation by technical SMEs and ensure appropriate archiving of source technical documents.

• Facilitate domestic and global regulatory lifecycle submissions through the management of supporting technical and regulatory documentation requests with external partners and vendors.

• Ensure continued regulatory compliance and phase-appropriate, risk-based approaches to manufacturing flexibility while adhering to change control procedures and health authority requirements.

• Contribute to the development and maintenance of working practices and procedures, as well as help update and maintain procedures, templates, and documents.

Essential Skills

• Strong background (3-5 years) in a technical field (CMC) in the pharma or biotech industry.

• Experience in analytical chemistry & development, QC testing, manufacturing operations, quality, chemical development, and biomanufacturing.

• Proficiency in technical or regulatory writing, including SOPs, tech reports, and regulatory documentation.

• Cross-functional experience and strong communication skills.

• Detail-oriented with experience in managing documents and systems.

• Proficient in advanced functions in Word and capable of using Style Sheets.

Additional Skills & Qualifications

• Familiarity with Regulatory Information Management (RIM) systems.

• Experience with the person Regulatory module is highly desirable.

• Experience with any other RIM systems like Documentum is beneficial.

• Understanding of Chemistry, Manufacturing, and Controls (CMC) knowledge through the support of manufacturing operations in a technical or quality role.

• Familiarity with Common Technical Document content templates and content expectations for IND/NDA/BLA/MAA or other regulatory documentation.

• Experience with electronic regulatory information management systems.

Work Environment

The position is located onsite in Alameda, CA. The work environment is collaborative, involving cross-functional teams and interaction with external partners and vendors.

Job Type & Location

This is a Contract position based out of Alameda, CA.

Pay and Benefits

The pay range for this position is $75.00 - $90.00/hr.

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: Medical, dental & vision Critical Illness, Accident, and Hospital 401(k) Retirement Plan Pre-tax and Roth post-tax contributions available Life Insurance (Voluntary Life & AD&D for the employee and dependents) Short and long-term disability Health Spending Account (HSA) Transportation benefits Employee Assistance Program Time Off/Leave (PTO, Vacation or Sick Leave)

Job Type & Location

This is a Contract position based out of Alameda, CA.

Application Deadline

This position is anticipated to close on Nov 25, 2026.

Workplace Type

This is a fully onsite position in Alameda,CA.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email [e-mail] for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.