Sr. Regulatory Compliance Specialist

Job Title: Sr Regulatory Compliance Specialist

Job Description

The Sr Regulatory Compliance Specialist is responsible for ensuring that our products and technical files align with applicable regulatory requirements, including global standards and testing requirements. This role supports customer inquiries, manages customer regulatory submissions, and monitors ongoing compliance with the standards to maintain and update product technical files. It also involves monitoring relevant standards to ensure that upcoming changes and revisions are communicated and implemented effectively.

Responsibilities

• Ensure product compliance with USP, EP, and other applicable global regulations and standards.
• Monitor regulatory updates applicable to our products and assess their impact on company procedures and products.
• Identify and support the 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.

Essential Skills

• Proficiency in USP, EP, regulatory compliance, and regulatory affairs.
• Experience in developing testing plans and technical files.
• Strong ability to interpret regulatory changes and updates.
• Experience in pharmaceutical regulatory compliance or quality assurance (4 to 7 years).
• 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.
• Strong understanding of cGMP documentation requirements.
• Excellent written and verbal communication skills.

Additional Skills & Qualifications

• Bachelor's degree in a science field.
• Direct experience in reviewing/interpreting USP/EP/regulatory standards and recommending/communicating implementation plans.
• Technical file creation and revision experience is required.

Work Environment

This role requires travel up to 25% of the time. The work environment is dynamic and involves collaboration with various departments, including Product Line Management and Engineering, to ensure comprehensive regulatory compliance. The position demands a high degree of accuracy in documentation and communication, fostering a commitment to maintaining the highest standards of product quality and regulatory adherence.

This is a Permanent position based out of Camarillo, CA.

The pay range for this position is $105000.00 - $110000.00/yr.

Medical vision dental 401k PTO holiday

This is a fully remote position.

This position is anticipated to close on Mar 23, 2026.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

Salary : $105,000 - $110,000