Hybrid RA CMC Senior Associate — Submissions & Strategy

Spectraforce Technologies; Raleigh (NC); Hybrid; USD 90,000 - 130,000; Full time

Job summary

Spectraforce Technologies seeks a Regulatory Affairs Senior Associate to work hybrid in the United States. The role involves delivering CMC regulatory strategies, preparing submissions (INDs/CTAs), and supporting life-cycle management with supervision.

Collaboration across RA, R&D, and operations is required to maximize first-pass approvals. Responsibilities include preparing regulatory submissions, ensuring data presentation, and responding to global information requests, under management

Qualifications

• Experience in pharmaceutical regulatory affairs with CMC focus.
• Ability to prepare and review regulatory submissions and strategies.
• Strong cross-functional coordination with technical teams and management.

Responsibilities

• Collaborate with technical team to prepare regulatory filing dossiers.
• Assess changes for regulatory impact and ensure documentation accuracy.
• Manage document control systems and related responsibilities.
• Participate in GRPT and Operations Brand Teams as needed.

Skills

CMC Regulatory experience

Regulatory submissions

Regulatory strategy

Cross-functional collaboration

Education

Bachelor's degree in Pharmacy/ Biology/ Chemistry/ Engineering

Job description

Spectraforce Technologies seeks a Regulatory Affairs Senior Associate to work hybrid in the United States. The role involves delivering CMC regulatory strategies, preparing submissions (INDs/CTAs), and supporting life-cycle management with supervision.

Collaboration across RA, R&D, and operations is required to maximize first-pass approvals. Responsibilities include preparing regulatory submissions, ensuring data presentation, and responding to global information requests, under management