Remote CMC Regulatory Strategist (Biologics)

Parexel; Richmond (VA); A distancia; USD 120.000 - 170.000; 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 Regulatory Affairs Consultant, CMC – Biologics to join our team in a remote capacity based. You will provide CMC regulatory strategy input and expertise for investigational, new, and marketed biologic and small molecule drug products.

This role covers the US, EU, and Canada, supporting regulatory submissions, health authority interactions, and continuous improvement of CMC processes within a fast‑paced, global team.

Formación

• Bachelor’s degree in Pharmaceutical Sciences or Chemistry or PharmD.
• 4–6 years of CMC experience in the pharmaceutical industry.
• Knowledge of GMP and regulatory filing processes (IND/NDA/DMF).
• Experience preparing CMC sections for regulatory submissions for FDA and global bodies.
• Proficient with MS Word, Excel, PowerPoint.

Responsabilidades

• Prepare and review CMC/GMP submissions for regulatory authorities.
• Develop CMC regulatory strategies for biologics and small molecules.
• Coordinate submissions and maintain regulatory documentation with cross‑functional teams.
• Represent CMC Regulatory Affairs in project team meetings and health authority meetings.
• Collaborate with manufacturing, quality, and external partners to resolve CMC issues.
• Support monthly CMC GRT meetings and regulatory planning activities.

Conocimientos

Strategic thinking

Analytical problem solving

Negotiation

Communication skills

Collaboration

Presentation skills

Multi-project management

Educación

Bachelor's degree in Pharmaceutical Sciences or Chemistry, or PharmD

Master's or PhD (preferred)

Regulatory Affairs Certification (RAC) (preferred)

Herramientas

TrackWise Digital

TRS Viewer

Microsoft Office

Descripción del empleo

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

This role covers the US, EU, and Canada, supporting regulatory submissions, health authority interactions, and continuous improvement of CMC processes within a fast‑paced, global team.