Global CMC Regulatory Director - Remote Leadership & Impact

Liquidia Corporation; Morrisville (NC); Hybrid; USD 120,000 - 160,000; Full time

Benefits offered by this job

Medical, Dental, and Vision insurance

401(k) Savings Retirement Plan

Unlimited Paid Time Off

Job summary

A leading biotechnology company based in North Carolina is seeking a Director for CMC Global Regulatory Affairs. This role is responsible for overseeing all regulatory and compliance activities throughout the product lifecycle. The ideal candidate should have over 10 years of experience in the pharmaceutical industry along with a strong background in regulatory strategies and FDA compliance. A competitive compensation package is offered, including several benefits and the possibility to work remotely.

Qualifications

• Minimum 10 years of CMC regulatory experience in the pharmaceutical industry.
• Strong knowledge of FDA and ICH regulatory requirements.
• Experience with authoring and filing INDs and NDAs.

Responsibilities

• Lead development of CMC and device regulatory submission strategies.
• Conduct risk assessments and develop mitigation strategies.
• Ensure compliance with regulations and guidelines.

Skills

Written and oral communication skills

Evaluative and analytical skills

Project management skills

Multi-tasking and prioritization

Regulatory strategies execution

Education

Bachelor’s degree in chemistry, biochemistry, engineering, or life sciences

Advanced degree preferred

RAC or similar certification

Job description

A leading biotechnology company based in North Carolina is seeking a Director for CMC Global Regulatory Affairs. This role is responsible for overseeing all regulatory and compliance activities throughout the product lifecycle. The ideal candidate should have over 10 years of experience in the pharmaceutical industry along with a strong background in regulatory strategies and FDA compliance. A competitive compensation package is offered, including several benefits and the possibility to work remotely.