Director, Regulatory Affairs – Licensure, DSCSA & Trade

Jobtailor; Kentucky; Hybrid; USD 150,000 - 190,000; Full time

Job summary

Jobtailor is seeking a senior Regulatory Affairs leader in a hybrid role in the United States. You will develop the 3PL regulatory strategy, own the risk framework, and oversee licensure programs across multiple facilities.

The role requires strong cross-functional leadership, executive communication, and extensive experience in DSCSA and pharmaceutical distribution. You will lead a small team of 3-4 professionals, drive governance and continuous improvement, and partner with stakeholders to

Qualifications

• Bachelors or equivalent in regulatory/healthcare fields as listed.
• At least 10+ years of progressive regulatory experience.
• At least 5+ years of people leadership.
• Knowledge of pharmaceutical distribution requirements.
• Experience leading cross-functional initiatives.
• Ability to travel ~25% and work in a hybrid environment.

Responsibilities

• Develop and execute 3PL regulatory affairs strategy for licensure and DSCSA.
• Own the regulatory risk framework, including risk assessment, control design and remediation.
• Establish governance, escalation thresholds, and decision rights.
• Provide executive leadership with exposure assessments and recommended actions.
• Represent the company during regulatory inspections and audits.
• Direct multi-facility licensure programs and manage renewals and reporting.
• Lead DSCSA product tracing, verification, and recordkeeping oversight.
• Lead regulatory governance for pharmaceutical and healthcare product movement.
• Coach and develop a team of 3-4 regulatory affairs professionals.
• Embed regulatory requirements into business processes and controls.

Skills

Regulatory strategy

DSCSA Compliance

Regulatory risk management

Cross-functional leadership

Executive communication

Education

Bachelor's degree or equivalent in Regulatory Affairs, Pharmacy, Life Sciences, Business Administration, Supply Chain Management, or a related field

Job description

Jobtailor is seeking a senior Regulatory Affairs leader in a hybrid role in the United States. You will develop the 3PL regulatory strategy, own the risk framework, and oversee licensure programs across multiple facilities.

The role requires strong cross-functional leadership, executive communication, and extensive experience in DSCSA and pharmaceutical distribution. You will lead a small team of 3-4 professionals, drive governance and continuous improvement, and partner with stakeholders to