VP, CMC Regulatory Affairs — Veterinary Longevity Drugs

OpenKrill; United States; On-site; USD 280,000 - 340,000; Full time

Benefits offered by this job

Health insurance

Home office stipend

Learning budget

Wellness budget

4-day weekends

Unlimited vacation

Paw-ternity leave

Equity options

Job summary

Loyal is seeking a Vice President, CMC Regulatory Affairs to lead the strategy and operations for all CMC regulatory activities across the company’s pipeline. The role drives the full regulatory program from early development through approval and post‑approval lifecycle management.

The candidate brings a deep CMC background in small molecule drug development, with a proven ability to lead teams, interact with agencies, and ensure compliance across global markets.

Qualifications

• Ph.D. or equivalent scientific expertise required.
• 18+ years in regulatory affairs with senior leadership experience.
• Strong CMC regulatory background in small molecule development.
• Proven track record leading regulatory teams and agency interactions.

Responsibilities

• Lead global CMC regulatory strategy across all programs from development to post‑approval.
• Oversee filing strategy, CMC section authorship, post‑approval changes, and CDMO regulatory oversight.
• Develop regulatory intelligence and communicate risk to leadership and board.

Skills

CMC Regulatory

Regulatory Strategy

Agency Interactions

Regulatory Leadership

Risk Management

Education

PhD in Pharmaceutical Sciences

Tools

eCTD Knowledge

Job description

Loyal is seeking a Vice President, CMC Regulatory Affairs to lead the strategy and operations for all CMC regulatory activities across the company’s pipeline. The role drives the full regulatory program from early development through approval and post‑approval lifecycle management.

The candidate brings a deep CMC background in small molecule drug development, with a proven ability to lead teams, interact with agencies, and ensure compliance across global markets.