Sr Global Regulatory Compliance Specialist

About the Company

SaniSure is a high-growth multinational manufacturer of single-use products and systems used in the production of biological drugs, including cell therapies, gene therapies, and vaccines. With operations in the U.S. and Europe, we supply global pharmaceutical and biotech companies with the critical tools they need to develop and manufacture some of today's most innovative and life-changing medicines. As we continue to expand our product offerings and global footprint, SaniSure offers an exciting opportunity to join a nimble, customer-focused company at the forefront of the biotech industry.

About the Role

The Senior Regulatory Compliance Specialist is responsible for ensuring that our products and technical files align with applicable regulatory requirements, including global pharmacopeias, relevant standards, and testing requirements. This role supports customer inquiries, customer regulatory submissions, and monitors ongoing compliance with the standards upon which SaniSure certifies. The Specialist will maintain and update product technical files and monitor relevant standards and pharmacopeias to ensure upcoming changes/revisions are communicated and implemented.

Responsibilities

• Ensure product compliance with USP, EP, and other applicable global regulations/standards.
• Monitor regulatory updates applicable to our products and assess impact on company procedures and products.
• Identify and support implementation of new or revised regulatory requirements.
• Provide recommendations for robust testing plans to ensure compliance based on upcoming and revised regulatory changes.
• Review, communicate, and remediate gaps in partnership with Product Line Management and Engineering for our product technical files.
• Perform other duties as assigned.

Requirements

• Bachelor's degree in Pharmacy, Chemistry, Life Sciences, or related field.
• Minimum 4 to 7 years of experience in pharmaceutical regulatory compliance or quality assurance.
• Direct experience in reviewing/interpreting USP/EP/regulatory standards and recommending/communicating implementation plans.
• Hands-on ownership of product technical files and regulatory documentation throughout the product lifecycle.
• Experience monitoring regulatory updates and implementing compliance changes across product portfolios.
• Technical file creation and revision experience required.
• Strong understanding of cGMP documentation requirements.
• Excellent written and verbal communication skills.
• Travel required up to 25% of the time.