Remote Senior Regulatory Affairs & Compliance Lead

Parexel International; Northern (KY); Hybrid; USD 90,000 - 130,000; Full time

Benefits offered by this job

Health Insurance

Tuition Reimbursement

Vacation/Holiday/Sick Time

Flexible Spending & Health Savings

Work/Life Balance

401(k) with Company match

Pet Insurance

Job summary

Parexel is seeking a Senior Regulatory Affairs Associate - Regulatory Compliance to join our Global Regulatory Affairs team in a remote capacity. You will support regulatory compliance from planning to execution, align with the Global Regulatory Compliance Lead, and collaborate with cross-functional teams to ensure SOP maintenance and inspection readiness.

You will contribute to regulatory excellence across GRA, participate in regulatory reporting, and help drive continuous improvement in

Qualifications

• 3+ years of general regulatory affairs experience and knowledge of the drug development process.
• 3 years of audit and inspection exposure and/or experience.
• Strong oral and written communication skills.
• Solid working knowledge and understanding of the drug development process, laws, regulations, and guidelines including FDA, ICH, and other regulatory requirements.

Responsibilities

• Coordinate GRA SOP revisions and maintain revision tracker.
• Support inspection readiness and audit notifications.
• Collaborate with Regulatory Intelligence and Pharmacovigilance on RRS updates.
• Prepare monthly regulatory milestone reports with stakeholders.
• Develop compliance communications and newsletters.
• Prepare and maintain cross-functional meeting materials and minutes.
• Maintain GRA portals, contact lists, and organizational charts.
• Ensure timely execution of plans and resolve deviations.

Skills

Regulatory compliance

Cross-functional collaboration

Process management

Documentation management

Education

Bachelor's degree in life sciences, scientific, or engineering field

Tools

EDMS

Job description

Parexel is seeking a Senior Regulatory Affairs Associate - Regulatory Compliance to join our Global Regulatory Affairs team in a remote capacity. You will support regulatory compliance from planning to execution, align with the Global Regulatory Compliance Lead, and collaborate with cross-functional teams to ensure SOP maintenance and inspection readiness.

You will contribute to regulatory excellence across GRA, participate in regulatory reporting, and help drive continuous improvement in