Remote: Regulatory Affairs & Process Compliance Lead

Regulatory Jobs; United States; Remote; USD 110.000 - 160.000; Vollzeit

Benefits dieser Stelle

Health, Vision & Dental Insurance

Tuition Reimbursement

Vacation/Holiday/Sick Time

Flexible Spending & Health Savings

Work/Life Balance

401(k) with Company match

Pet Insurance

Zusammenfassung

Parexel is seeking a Regulatory Affairs Consultant, Process & Compliance to join remotely, supporting a large client program. You will manage controlled documents in Veeva Quality, ensuring inspection readiness and regulatory compliance across global operations.

You will collaborate with cross-functional teams, maintain training governance, and drive quality improvements within GxP frameworks, helping protect patient safety and therapy integrity.

Qualifikationen

• Bachelor's degree in Life Sciences, Pharmacy, Biotechnology, Engineering, or related field.
• 8+ years of experience in regulatory compliance, quality assurance, regulatory affairs, or related GxP functions.
• Strong knowledge of FDA, EMA, ICH, and global GxP regulations.
• Experience supporting regulatory inspections, audit management, and inspection readiness.
• Experience with document control processes, procedural governance, and Veeva Vault or similar eDMS.
• Experience supporting GxP training governance processes and LMS usage.
• Understanding of role-based training requirements and inspection expectations related to personnel qualification and training documentation.
• Strong analytical and communication skills.

Aufgaben

• Serve as a SME for controlled document management within Veeva Quality, ensuring compliant document governance and inspection readiness across Regulatory and Quality operations.
• Author, format, review, approve, and manage controlled procedures and quality documents per GxP requirements and internal standards, covering lifecycle from creation to obsolescence.
• Support and lead regulatory compliance activities across global GxP operations with cross-functional teams to assess and mitigate risks.
• Drive inspection readiness initiatives and support regulatory inspections by FDA, EMA, MHRA and others, including remediation plans for findings.
• Oversee GxP training governance, maintain curricula aligned with roles, and ensure LMS-based assignment, completion, tracking, and documentation for inspection readiness.
• Monitor training compliance metrics and remediate overdue or non-compliant training records.
• Collaborate with Regulatory Affairs, Quality, CMC, Clinical Operations, Pharmacovigilance, and Medical Writing to provide compliance guidance for activities and initiatives.

Kenntnisse

Controlled document management

GxP training governance

Cross-functional collaboration

Clear communication

Attention to detail

Quality mindset

Ausbildung

Bachelor's degree in Life Sciences, Pharmacy, Biotechnology, Engineering, or related field

Tools

Veeva Vault

LMS

Jobbeschreibung

Parexel is seeking a Regulatory Affairs Consultant, Process & Compliance to join remotely, supporting a large client program. You will manage controlled documents in Veeva Quality, ensuring inspection readiness and regulatory compliance across global operations.

You will collaborate with cross-functional teams, maintain training governance, and drive quality improvements within GxP frameworks, helping protect patient safety and therapy integrity.