Regulatory Operations Specialist - Temporary

Twist Bioscience; South San Francisco (CA); On-site; USD 65,000 - 88,000; Full time

Job summary

Twist Bioscience is seeking a Regulatory Operations Specialist in the San Francisco Bay Area to lead SDS creation, documentation, and regulatory compliance across global markets.

You will collaborate with R&D, QA, and regulatory teams to obtain data, manage SDS lifecycle, and maintain SOPs while adhering to ISO 13485 and internal policies. Travel up to 5% may be required.

Qualifications

• Bachelor’s degree in a scientific discipline (e.g., Chemistry, Biology, Biochemistry) or equivalent.
• Minimally 2 years of experience Regulatory Operations in biotech, life sciences, or chemical manufacturing or another regulated industry.
• Expertise in developing technical documentation including Safety Data Sheets (SDS), SOPs, and work instructions.
• Familiarity with Quality Management Systems and electronic document control systems (eQMS).
• Experience with Google Suite and/or MS Office products.
• Experience with Master Control, Atlassian Confluence and/or JIRA.
• Strong written and oral communication skills; ability to tailor messaging to the audience.

Responsibilities

• Initiate, author, and maintain SDS for all Twist products, ensuring global regulatory compliance.
• Collaborate with cross-functional teams to obtain product composition data and hazard information for SDS generation.
• Manage review, approval, and distribution of SDS to internal and external stakeholders.
• Ensure compliance with business policies and procedures.
• Perform day-to-day administration on EQMS per approved procedures.
• Collaborate with Business Process Owner to document configuration changes in EQMS to meet needs.
• Perform other duties and projects as assigned.
• Travel up to 5% of time.
• Follow regulatory and ISO 13485 requirements.

Skills

Strong written and oral communication

Adaptable / flexible

Education

Bachelor's degree in scientific discipline

Tools

Master Control

Atlassian Confluence

JIRA

EQMS

Google Suite

MS Office

Job description

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.
• Carry 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.

San Francisco Bay Area Pay Range

$31 — $42 USD