Regulatory Operations Specialist - Temporary

About the role

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.

Responsibilities

• 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 needs.
• Perform other duties & projects as assigned.
• Ability to travel 5%
• Follow regulatory and ISO 13485 requirements.

Requirements

• 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.

Qualifications

None specified.

Skills

• Technical Documentation Development
• Quality Management Systems
• Electronic Document Control Systems
• Google Suite and/or MS Office Products
• Master Control, Atlassian Confluence and/or JIRA
• Written and Oral Communication
• Flexibility and Adaptability

Benefits

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.

Pay

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.

Schedule

Not specified.