Remote Senior CMC Regulatory Lead, Post-Approval Vaccines

ATLAS MEDICAL SERVICES LTD. STI.; United States; A distancia; USD 150.000 - 190.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health, Vision & Dental Insurance

Tuition Reimbursement

Vacation/Holiday/Sick Time

401(k) with Company match

Pet Insurance

Descripción de la vacante

Parexel is seeking an experienced Senior Regulatory Affairs Consultant (CMC) to lead post-approval vaccine regulatory activities in a remote United States capacity. The role focuses on strategic CMC leadership, health authority engagement, and key lifecycle management for late-stage and marketed vaccines.

You will collaborate with R&D, Manufacturing, Quality Assurance, and Clinical Development to shape CMC strategy, author submissions, and guide regulatory conversations with authorities.

Formación

• Advanced degree required in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or related field.
• 10+ years in Regulatory Affairs with CMC focus on late-stage and marketed products.
• Global CMC regulatory requirements and health authority expectations knowledge.

Responsabilidades

• Provide strategic CMC direction for late-stage and marketed products across development lifecycle.
• Lead high-level regulatory submissions and health authority interactions.
• Coordinate cross-functional teams to address regulator questions and manage lifecycle changes.

Conocimientos

CMC strategy

Health authority engagement

Regulatory submissions

Leadership

Cross-functional collaboration

Educación

Advanced degree (PharmSci/chem/engineering)

Descripción del empleo

Parexel is seeking an experienced Senior Regulatory Affairs Consultant (CMC) to lead post-approval vaccine regulatory activities in a remote United States capacity. The role focuses on strategic CMC leadership, health authority engagement, and key lifecycle management for late-stage and marketed vaccines.

You will collaborate with R&D, Manufacturing, Quality Assurance, and Clinical Development to shape CMC strategy, author submissions, and guide regulatory conversations with authorities.