Remote CMC Regulatory Affairs Consultant - Biologics

Parexel; Madison (WI); 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 is seeking a Regulatory Affairs Consultant, CMC – Biologics to join our team in a remote capacity. You will provide CMC regulatory strategy input for investigational, new, and marketed biologic and small molecule products, with primary responsibility for the US, EU, and Canada to support timely approvals.

Collaborate with Regulatory Affairs leads and cross-functional partners to prepare CMC and GMP submissions, and support health authority meetings from development through post-approval

Qualifikationen

• Bachelor's degree in Pharmaceutical Sciences or Chemistry, or a Pharm.D.
• 4-6 years of CMC experience in the pharmaceutical industry with regulatory filing experience
• Knowledge of the drug development process, GMP, and related issues
• 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 for Europe/Canada
• Understanding of the global regulatory environment
• Proficiency with Microsoft Word, Excel, PowerPoint, Outlook
• Strong analytical, problem-solving, organizational, and negotiation skills

Aufgaben

• Develop CMC regulatory strategies and contingency plans for biologics and small molecules
• Develop CMC strategies for development-phase products and post-approval changes
• Determine regulatory and scientific requirements for CMC/GMP submissions
• Prepare, coordinate, and review CMC/GMP documents for regulatory submissions
• Represent CMC Regulatory Affairs in project meetings and with cross-functional teams
• Prepare for health authority CMC meetings and plan mock meetings
• Support monthly CMC GRT meetings with global teams
• Interact with manufacturing and quality groups and external partners
• Develop relationships with global functional units and suppliers
• Prepare departmental procedures
• Identify ideas to improve CMC Regulatory Affairs processes

Kenntnisse

Strategic thinking

Analytical problem solving

Negotiation

Collaboration

Communication

Meeting leadership

Ausbildung

Bachelor's in Pharmaceutical Sciences or Chemistry

Tools

TrackWise Digital

TRS Viewer

Jobbeschreibung

Parexel is seeking a Regulatory Affairs Consultant, CMC – Biologics to join our team in a remote capacity. You will provide CMC regulatory strategy input for investigational, new, and marketed biologic and small molecule products, with primary responsibility for the US, EU, and Canada to support timely approvals.

Collaborate with Regulatory Affairs leads and cross-functional partners to prepare CMC and GMP submissions, and support health authority meetings from development through post-approval