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 May 18, 2026.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I is embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

Actalent is an equal opportunity employer.

About Actalent

Actalent is a global leader in engineering and sciences services. For more than 40 years, we’ve helped visionary companies advance their goals. Headquartered in the United States, our teams span 150 offices across North America, EMEA, and APAC—with four delivery centers in India led by 1,000 extraordinary employees who connect their passion with purpose every day.

Our Bangalore, Hyderabad, Pune, and Chennai delivery centers are hubs of engineering expertise, with core capabilities in mechanical and electrical engineering, systems and software, and manufacturing engineering. Our teams deliver work across multiple industries including transportation, consumer and industrial products, and life sciences. We serve more than 4,500 clients, including many Fortune 500 brands. Learn more about how we can work together at actalentservices.com.

Salary : $105,000 - $110,000