Remote Regulatory Affairs Consultant, CMC – Biologics

Parexel; Pierre (SD); Remote; USD 120.000 - 160.000; Vollzeit

Benefits dieser Stelle

Health, Vision & Dental Insurance

Tuition Reimbursement

Vacation/Holiday/Sick Time

Flexible Spending & Health Savings

Work/Life Balance

401(k) with company match

Pet Insurance

Zusammenfassung

Parexel, a global clinical development partner, is seeking a Regulatory Affairs Consultant, CMC – Biologics, to join our team in a remote capacity. You will provide regulatory strategy input for biologics and small molecules, coordinate CMC GMP documentation for US, EU, and Canada, and collaborate with cross-functional teams to support approvals and post-approval changes.

This fast-paced role offers opportunities to influence program outcomes and advance your career in regulatory affairs and

Qualifikationen

• Bachelor's degree in Pharmaceutical Sciences or Chemistry, or Pharm.D.
• 4–6 years of CMC experience in the pharmaceutical industry with regulatory filing history
• Comprehensive knowledge of the drug development process, GMP, and global regulatory requirements
• Knowledge of CMC regulatory requirements for biologics and small molecules during development and post-approval
• Experience preparing CMC (Quality) sections for IND, NDA, DMF for FDA and equivalents in Europe/Canada
• Demonstrated experience with regulatory information systems and MS Office

Aufgaben

• Develop and implement CMC regulatory strategies for biologics and small molecules
• Prepare, coordinate, and review CMC and GMP documents for regulatory submissions
• Represent CMC Regulatory Affairs in project team meetings and cross-functional groups
• Support health authority CMC meetings and monthly GRT meetings
• Build and maintain relationships with manufacturing sites, quality, and external partners

Kenntnisse

Strategic thinking

Analytical problem solving

Negotiation

Collaboration

Communication skills

Regulatory knowledge

Document management

Ausbildung

Bachelor's in Pharmaceutical Sciences or Chemistry

Pharm.D.

Regulatory Affairs Certification (RAC)

Tools

TrackWise Digital

TRS Viewer

Microsoft Office (Word/Excel/PowerPoint/Outlook)

Jobbeschreibung

Parexel, a global clinical development partner, is seeking a Regulatory Affairs Consultant, CMC – Biologics, to join our team in a remote capacity. You will provide regulatory strategy input for biologics and small molecules, coordinate CMC GMP documentation for US, EU, and Canada, and collaborate with cross-functional teams to support approvals and post-approval changes.

This fast-paced role offers opportunities to influence program outcomes and advance your career in regulatory affairs and