Senior Regulatory Compliance Specialist - Remote

Regulatory Jobs; United States; A distancia; USD 90.000 - 130.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health, Vision & Dental Insurance

Tuition Reimbursement

Vacation/Holiday/Sick Time

Flexible Spending & Health Savings

Work/Life Balance

401(k) with Company match

Pet Insurance

Descripción de la vacante

Parexel is seeking a Senior Regulatory Affairs Associate - Regulatory Compliance to join our team in a remote capacity from the United States. You will support regulatory compliance activities from planning to execution, align with the Global Regulatory Compliance Lead, and work with cross-functional teams to maintain SOPs, GxP compliance, and inspection readiness.

You will contribute to regulatory excellence across Global Regulatory Affairs, with opportunities to grow in regulatory compliance

Formación

• Bachelor's degree in life sciences, scientific, or engineering field.
• 3+ years of general regulatory affairs experience and knowledge of the drug development process in the pharmaceutical industry.
• 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.

Responsabilidades

• Function as SOP Coordinator supporting Global Regulatory Affairs (GRA) SOP revisions and related activities.
• Support inspection readiness activities including inspection calendar and CAPA tracking.
• Collaborate with Regulatory Intelligence and Pharmacovigilance to update Regulatory Requirements Summary (RRS).
• Prepare monthly reports for KPIs and post results on the GRA Collaboration Portal.
• Provide meeting support for cross-functional GRA meetings and document outcomes.

Conocimientos

Regulatory compliance

Cross-functional collaboration

Regulatory affairs experience

Documentation management systems

Attention to detail

Organizational skills

Communication skills

Problem-solving

Educación

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

Herramientas

Veeva Vault

Monday.com

Microsoft Office

EDMS

GxP systems

Descripción del empleo

Parexel is seeking a Senior Regulatory Affairs Associate - Regulatory Compliance to join our team in a remote capacity from the United States. You will support regulatory compliance activities from planning to execution, align with the Global Regulatory Compliance Lead, and work with cross-functional teams to maintain SOPs, GxP compliance, and inspection readiness.

You will contribute to regulatory excellence across Global Regulatory Affairs, with opportunities to grow in regulatory compliance