Regulatory Affairs Consultant

Job Description

CMC Regulatory Consultant (6-12 Month Contract // REMOTE)

Part-time - 10-20+ hours per week

Summary:

CMC Regulatory Expert needed to support INDa submission activities and related responsibilities

Duties & Responsibilities:

• Provide Subject Matter Expert-level guidance for submission structure and content
• Review submission draft for Module 3 compliance, overall accuracy and completeness, and provide overall CMC regulatory strategy guidance
• Provide general feedback for IND filing and amendments
• Collaboration with internal stakeholders and other related personnel
• Provide submission readiness sign-off
• Other duties, as required

Qualifications & Requirements :

• Solid experience CMC Regulatory strategy, content and authoring expertise for viral vector or microbial systems Phase II INDa submissions
• Extensive track record of managing, authoring and editing multiple FDA regulatory submissions
• Strong understanding of biologics Chemistry, Manufacturing and Controls and related compliance
• Excellent written, verbal and interpersonal communication skills
• Relevant degree

Location:

Work can be performed remotely from home