JOB DESCRIPTION
Title: Global Sr. Regulatory Compliance Specialist Department: Quality
Reports To: Chief Quality Officer FLSA Status: Exempt
Job Summary
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 the company certifies to and will maintain and update product technical files and monitor relevant standards and pharmacopeias to ensure that upcoming changes/revisions are communicated and implemented.
Essential Functions
- Ensure product compliance with:
- 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 additional job duties as assigned.
Education / Certifications
Bachelor's degree in Pharmacy, Chemistry, Life Sciences, or related field
Required Experience & Competencies
- 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 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 10%