Remote Senior Director, Quality & CMC Strategy

Piper Companies; United States; Remote; USD 250,000 - 290,000; Full time

Benefits offered by this job

Medical, Dental, Vision

Paid Time Off

401(k)

Job summary

Piper Companies is seeking a Senior Director, Quality & CMC Regulatory Strategy to guide regulatory strategy from development through lifecycle management for biotechnology and pharmaceutical clients. The role focuses on leading global CMC activities, client liaison, and cross-functional collaboration to ensure compliant submissions and strategic impact.

The ideal candidate brings 15+ years in Regulatory Affairs/CMC, deep FDA and global regulatory knowledge, and proven leadership in

Qualifications

• Bachelor's degree in a scientific discipline is required; advanced degree preferred.
• 15+ years of experience in Regulatory Affairs, CMC, Quality, biotech or pharma.
• Extensive knowledge of FDA regulations, global regulatory requirements, and CMC submission strategies.
• Experience supporting biologics, small molecules, and novel therapeutic platforms across the product lifecycle.
• Proven leadership experience managing regulatory teams and serving as a client-facing advisor.

Responsibilities

• Lead global CMC regulatory strategies for development, registration, and post-approval programs.
• Serve as a trusted advisor to clients on regulatory pathways, submission planning, and health authority interactions.
• Oversee the preparation and review of INDs, amendments, global filings, and lifecycle management submissions.
• Collaborate with quality, manufacturing, and development teams to ensure regulatory compliance and execution.
• Mentor regulatory professionals while supporting client engagement and business growth initiatives.

Skills

Regulatory strategy

CMC

FDA regulations

Global regulatory

Client advisory

Leadership

Education

Bachelor's degree in a scientific discipline

Advanced degree preferred

Job description

Piper Companies is seeking a Senior Director, Quality & CMC Regulatory Strategy to guide regulatory strategy from development through lifecycle management for biotechnology and pharmaceutical clients. The role focuses on leading global CMC activities, client liaison, and cross-functional collaboration to ensure compliant submissions and strategic impact.

The ideal candidate brings 15+ years in Regulatory Affairs/CMC, deep FDA and global regulatory knowledge, and proven leadership in