Regulatory Operations Specialist - Temporary

TWIST BIOSCIENCE; San Francisco (CA); On-site; USD 42,705 - 57,859; Full time

Job summary

TWIST BIOSCIENCE in South San Francisco, CA is seeking a Regulatory Operations Specialist (Temporary) to lead SDS development, labeling, and SOP documentation. You will work across functions to ensure compliance and accurate regulatory materials.

The role involves EQMS administration, collaborative data gathering, and adherence to global regulatory standards. Travel up to 5% may be required in a fast-paced biotech environment.

Qualifications

• Bachelor’s degree in a scientific discipline or equivalent experience.
• 2+ years in Regulatory Operations within biotech, life sciences, or related field.
• Experience developing SDS, SOPs, and work instructions.

Responsibilities

• Initiate, author, and maintain Safety Data Sheets (SDS) for all Twist products.
• Collaborate with cross-functional teams to obtain product data for SDS accuracy.
• Manage review, approval, and distribution of SDS to stakeholders.
• Perform day-to-day EQMS administration per procedures.
• Document configuration changes with Business Process Owner and EQMS users.
• Carry out additional duties and projects as assigned.
• Travel up to 5% as required.
• Follow ISO 13485 and regulatory requirements.

Skills

SDS knowledge

Documentation

SOP writing

eQMS familiarity

Google Suite

MS Office

Communication

Adaptability

Education

Bachelor’s degree in a scientific discipline

Tools

Master Control

Confluence

JIRA

Job description

Regulatory Operations Specialist - Temporary

USA - South San Francisco, CA

The Regulatory Operations Specialist is responsible for ensuring the efficient and compliant management of regulatory documentation, with a primary focus on Safety Data Sheets (SDS), product labeling, and SOP’s. This role is crucial in supporting global product compliance, ensuring that all documentation accurately reflects regulatory requirements and product specifications.

What You’ll Be Doing

• Initiate, author, and maintain Safety Data Sheets (SDS) for all Twist products, ensuring compliance with global regulations.
• Collaborate with cross-functional teams to obtain necessary product composition data and hazard information for accurate SDS generation.
• Manage the review, approval, and distribution of SDS to internal and external stakeholders.
• Carries out duties in compliance with established business policies.
• Perform day to day administration activities on EQMS as per approved procedures.
• Work closely and collaborate with the Business Process Owner and EQMS users to develop and document configuration changes to meet business need
• Perform other duties & projects as assigned.
• Ability to travel 5%
• Follow regulatory and ISO 13485 requirements.

What You’ll Bring to the Team

• Bachelor’s degree in a scientific discipline (e.g., Chemistry, Biology, Biochemistry) or equivalent combination of education and work-related experience.
• Minimally 2 years of experience Regulatory Operations within a biotechnology, life sciences, or chemical manufacturing company or another Regulated Industry.
• Expertise in developing technical documentation, including Safety Data Sheets (SDS), SOP, and work instructions
• Familiarity with Quality Management Systems and electronic document control systems (eQMS)
• Experience with Google Suite and/or MS Office Products required.
• Experience with Master Control, Atlassian Confluence and/or JIRA preferred.
• Strong written and oral communication skills (timely, clear, concise, accurate, conclusive, influential, targeted to audience) required.
• Flexible, with ability to work effectively in a fast-paced, dynamic environment with shifting and competing demands is required

The base cash compensation for this California-based role is below. In addition to base salary, this role is eligible for bonus, equity, and a generous benefits package. Final compensation amounts are determined by multiple factors, including candidate skill, experience, expertise, and location and may vary from the amount listed above. Compensation may be different in other locations.

$31 - $42 USD