Regulatory Affairs Specialist

Regulatory Affairs Specialist (Lexington, KY Site)

Our Work Matters

At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world.

Our Work Matters
As a Regulatory Affairs Specialist at Kindeva, your role is essential to ensuring our products remain compliant, safe, and accessible to patients worldwide. From managing licenses and technical documentation to supporting regulatory strategy and site activities, your work helps maintain the integrity of our drug and device portfolio.

Your attention to detail and regulatory expertise directly support patient safety and product quality—because at Kindeva, every submission, every renewal, and every guideline met makes a difference.

Responsibilities:

• Provide regulatory input to site teams and advise stakeholders on global regulatory requirements for planned and unplanned changes.
• Coordinate and prepare documentation for medical device listings, site registrations, and CTD submissions.
• Maintain site regulatory files and support activities for annual license renewals, DEA/state licenses, and new regulatory filings.
• Participate in technical reviews to ensure data aligns with global guidelines and regulatory requirements.
• Support post-approval regulatory submissions and lifecycle management.
• Communicate regulatory expectations and timelines within the organization.
• Contribute to continuous improvement by sharing regulatory insights from external feedback and cross-functional projects.

Basic Qualifications:

• Bachelor’s degree in a scientific discipline
• At least 3 years of experience in pharmaceutical cGMP regulatory compliance.
• Practical knowledge of the drug regulatory processes in the US and background understanding of regulatory processes in other regions.
• General understanding of drug development and pharmaceutical manufacturing from concept to launch including requirements for product development, manufacturing, and marketing and the impact of regulatory changes on business goals/objectives.
• Able to communicate effectively orally and in writing
• Able to work both as part of a cross-functional team but also act independently.
• Knowledge of cGMPs, cleanrooms, pharmaceutical processing, and plant equipment.
• Self-starting with outstanding work ethic; must be able to perform in a fast-paced multi-product environment.

Physical Requirements:

• Must be able to read, comprehend, and follow documentation related to GMP and safety procedures.
• May be required to lift or move up to 20 pounds.
• Must follow all GMP and safety procedures in the department.
• Specific vision requirements include close vision, distance vision, color vision, and the ability to adjust and focus.

#LI-Onsite

California residents should review our Notice for California Employees and Applicants before applying. 
 
 

Kindeva Drug Delivery is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law.

Do you see yourself as part of the Kindeva mission? Click Apply Now Today!