Senior Director, Regulatory & Enterprise Risk

FFF Enterprises, Inc.; Temecula (CA); On-site; USD 180,000 - 260,000; Full time

Job summary

FFF Enterprises, Inc. is seeking a Director, Regulatory & Enterprise Risk to provide practical regulatory legal counsel across pharmaceutical distribution, specialty pharmacy and related healthcare businesses.

The role reports to the General Counsel and leads elements of enterprise risk governance and ERM reporting. The ideal candidate has substantial healthcare or pharmaceutical regulatory experience, strong business judgment and the ability to advise across multiple regulated business models.

Qualifications

• 7–10+ years of healthcare, pharmaceutical or life-sciences regulatory legal experience.
• Meaningful experience advising regulated healthcare or pharmaceutical businesses.
• Working knowledge of FDA/FDCA, DSCSA, DEA, CMS/federal healthcare program, HIPAA/privacy and related regulatory frameworks.
• Ability to advise across multiple regulated business models and elevate significant issues to leadership.

Responsibilities

• Provide regulatory legal counsel across pharmaceutical distribution, specialty pharmacy and related healthcare businesses.
• Lead elements of the enterprise risk governance process and ERM reporting.
• Monitor regulatory developments and translate them into practical business guidance for leaders.
• Advise on regulatory issues involving controlled substances, specialty pharmacy, Medicare/Medicaid, and payer regulations.
• Collaborate with Compliance, Licensing and other functions to implement regulatory requirements.

Skills

Regulatory law

Healthcare regulation

Regulatory governance

Legal advisory

Education

J.D. from an accredited law school

Bar admission in US jurisdiction

Job description

FFF Enterprises, Inc. is seeking a Director, Regulatory & Enterprise Risk to provide practical regulatory legal counsel across pharmaceutical distribution, specialty pharmacy and related healthcare businesses.

The role reports to the General Counsel and leads elements of enterprise risk governance and ERM reporting. The ideal candidate has substantial healthcare or pharmaceutical regulatory experience, strong business judgment and the ability to advise across multiple regulated business models.