Remote CMC Regulatory Affairs Consultant (Biologics)

Parexel; Jackson (MS); A distancia; USD 110.000 - 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 seeks a Regulatory Affairs Consultant, CMC – Biologics, for a remote-capable role. You will provide CMC regulatory strategy input for biologic and small molecule products, supporting US, EU, and Canada approvals and ongoing compliance.

You will prepare and review CMC and GMP documents, collaborate with cross-functional teams, and participate in health authority meetings. This fast-paced role offers growth, global exposure, and the chance to influence program outcomes.

Formación

• Experience in regulated pharmaceutical environment and ability to prepare regulatory filings.
• Knowledge of CMC regulatory requirements for biologics and small molecules.
• Ability to prepare high-quality technical documents and submissions.

Responsabilidades

• Develop and implement CMC regulatory strategies for biologics and small molecules.
• Prepare and review CMC and GMP submissions for health authorities.
• Participate in health authority meetings and cross-functional team discussions.
• Collaborate with manufacturing, quality, and regulatory teams to ensure compliant submissions.

Conocimientos

Strategic thinking

Problem solving

Pharma industry

Collaboration

Document preparation

Multi-project management

Regulatory systems

Educación

Pharmaceutical Sciences

Chemistry

Pharm.D.

Herramientas

Microsoft Office

Trackwise Digital

TRS Viewer

Descripción del empleo

Parexel seeks a Regulatory Affairs Consultant, CMC – Biologics, for a remote-capable role. You will provide CMC regulatory strategy input for biologic and small molecule products, supporting US, EU, and Canada approvals and ongoing compliance.

You will prepare and review CMC and GMP documents, collaborate with cross-functional teams, and participate in health authority meetings. This fast-paced role offers growth, global exposure, and the chance to influence program outcomes.