Remote CMC Regulatory Consultant - Biologics

Parexel; Honolulu (HI); Remote; USD 120.000 - 180.000; Vollzeit

Benefits dieser Stelle

Health Insurance

Tuition Reimbursement

Vacation/Holiday/Sick Time

401(k) with Company match

Pet Insurance

Zusammenfassung

Parexel seeks a Regulatory Affairs Consultant, CMC – Biologics to join our team in a remote capacity. You will provide CMC regulatory strategy input for biologics and small molecules, ensuring compliance across the US, EU, and Canada to support timely approvals and continued marketing.

You will prepare CMC and GMP documentation, support health authority meetings, and collaborate with cross-functional partners to influence program outcomes in a fast-paced, globally focused environment.

Qualifikationen

• Experience preparing regulatory filing documentation for CMC
• Knowledge of GMP, drug development, and global regulatory requirements
• Experience with IDE/NDA/DMF submissions for FDA and equivalents
• Ability to prepare high-quality regulatory documents and submissions

Aufgaben

• Develop and implement CMC regulatory strategies for biologics and small molecules
• Prepare and review CMC and GMP submissions to health authorities
• Represent CMC Regulatory Affairs in cross-functional project teams
• Support health authority CMC meetings and periodic GRT meetings
• Collaborate with manufacturing, quality, and external partners to ensure compliance

Kenntnisse

CMC regulatory expertise

Biologics knowledge

Regulatory submissions

Cross-functional collaboration

Regulatory strategy

Ausbildung

Bachelor's in Pharmaceutical Sciences or Chemistry

Pharm.D.

Master/Ph.D. preferred

Tools

TrackWise Digital

TRS Viewer

Jobbeschreibung

Parexel seeks a Regulatory Affairs Consultant, CMC – Biologics to join our team in a remote capacity. You will provide CMC regulatory strategy input for biologics and small molecules, ensuring compliance across the US, EU, and Canada to support timely approvals and continued marketing.

You will prepare CMC and GMP documentation, support health authority meetings, and collaborate with cross-functional partners to influence program outcomes in a fast-paced, globally focused environment.