Remote CMC Regulatory Affairs Consultant — Biologics

Parexel; Helena (MT); A distancia; USD 120.000 - 170.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health Insurance

Vision Insurance

Dental Insurance

Tuition Reimbursement

Paid Time Off

Flexible Spending Account

Health Savings Account

Work/Life Balance

401(k) with company match

Pet Insurance

Descripción de la vacante

Parexel is seeking a Regulatory Affairs Consultant, CMC – Biologics to join our team in a remote capacity. You will provide CMC regulatory strategy input for investigational, new, and marketed biologic and small molecule products, ensuring compliance with global regulatory requirements.

This role involves collaboration with manufacturing, quality, and regulatory leads, plus representation in project teams and health authority meetings to influence program outcomes.

Formación

• Bachelor's degree in Pharmaceutical Sciences or Chemistry or Pharm.D. required.
• 4–6 years of CMC experience in pharma with regulatory filing experience.
• Knowledge of GMP, drug development, and global CMC regulatory requirements.

Responsabilidades

• Develop CMC regulatory strategies for biologics and small molecule products.
• Prepare and review CMC and GMP submissions for regulatory authorities.
• Represent CMC Regulatory Affairs in project team meetings and with health authorities.
• Coordinate with cross-functional teams including manufacturing, quality, and regulatory leads.
• Support health authority CMC meetings and post-approval changes.

Conocimientos

Strategic thinking

Analytical skills

Negotiation

Communication

Presentation skills

Cross-functional collaboration

Regulatory affairs experience

Project management

Documentation

Educación

Bachelor's degree in Pharmaceutical Sciences or Chemistry

Pharm.D.

Master's or Ph.D. in related field

Herramientas

TrackWise Digital

TRS Viewer

Microsoft Office Suite

Descripción del empleo

Parexel is seeking a Regulatory Affairs Consultant, CMC – Biologics to join our team in a remote capacity. You will provide CMC regulatory strategy input for investigational, new, and marketed biologic and small molecule products, ensuring compliance with global regulatory requirements.

This role involves collaboration with manufacturing, quality, and regulatory leads, plus representation in project teams and health authority meetings to influence program outcomes.