Remote CMC Regulatory Affairs Consultant - Biologics

Parexel; Dover (DE); Remoto; USD 110.000 - 165.000; Tempo pieno

Vantaggi offerti da questo lavoro

Health, Vision & Dental Insurance

401(k) match

Tuition Reimbursement

Vacation/Holiday/Sick Time

Work/Life Balance

Pet Insurance

Descrizione del lavoro

Parexel is seeking a Regulatory Affairs Consultant, CMC – Biologics to join our team in a remote capacity. You will provide CMC regulatory strategy input and expertise for biologics and small molecule drug products, focusing on the US, EU, and Canada to support timely approvals and continued marketing.

Responsibilities include preparing and reviewing CMC and GMP documentation, representing CMC regulatory affairs in project teams, and supporting monthly global CMC GRT meetings while collaborating

Competenze

• 4-6 years of CMC experience in the pharmaceutical industry
• Experience preparing CMC sections for IND/NDA/DMF submissions
• Knowledge of GMP, drug development processes, and global regulatory requirements
• Ability to prepare high-quality regulatory documents and submissions

Mansioni

• Prepare, coordinate, and review CMC and GMP-related documents for regulatory submissions
• Support health authority CMC meetings and regulatory strategy
• Collaborate with cross-functional teams across manufacturing, quality, Technical Operations, affiliates, and external partners
• Develop and maintain regulatory processes and SOPs to improve efficiency

Conoscenze

Strategic thinking

Analytical problem solving

Negotiation

Collaborative communication

Regulatory affairs experience

Formazione

Bachelor's degree in Pharmaceutical Sciences or Chemistry

Pharm.D.

Master's or Ph.D. in related field

Strumenti

TrackWise Digital

TRS Viewer

Microsoft Word

Microsoft Excel

PowerPoint

Outlook

Descrizione del lavoro

Parexel is seeking a Regulatory Affairs Consultant, CMC – Biologics to join our team in a remote capacity. You will provide CMC regulatory strategy input and expertise for biologics and small molecule drug products, focusing on the US, EU, and Canada to support timely approvals and continued marketing.

Responsibilities include preparing and reviewing CMC and GMP documentation, representing CMC regulatory affairs in project teams, and supporting monthly global CMC GRT meetings while collaborating