Position Summary
The Director, Regulatory & Enterprise Risk is a senior attorney responsible for providing practical regulatory legal counsel across the Company's pharmaceutical distribution, specialty pharmacy and related healthcare businesses and for helping develop and administer the Company's enterprise risk management program.
Reporting to the General Counsel, the Director will serve as a primary regulatory legal resource for business and functional leaders, independently advising on complex regulatory matters, monitoring significant legal and regulatory developments and helping translate regulatory requirements into practical business guidance.
The Director will also lead key elements of the Company's enterprise risk governance process, working collaboratively with Compliance and other functions and building upon the existing annual ERM survey and reporting process.
The position requires substantial healthcare or pharmaceutical regulatory experience, strong business judgment and the ability to advise across multiple regulated business models.
Key Responsibilities
Regulatory Change Management
Establish and maintain a structured process to:
Monitor significant regulatory developments affecting the Company's businesses.
Assess applicability and potential business impact.
Communicate actionable regulatory developments to affected stakeholders.
Identify responsible business owners.
Define implementation requirements and deadlines.
Track implementation of significant regulatory changes.
Document material regulatory decisions and implementation status.
Identify and escalate implementation gaps presenting significant legal or business risk.
Pharmaceutical Distribution Regulation
Provide regulatory legal advice regarding:
Federal and state pharmaceutical distribution requirements.
FDA and Federal Food, Drug, and Cosmetic Act requirements affecting wholesale distribution activities.
Drug Supply Chain Security Act requirements.
EPCIS and electronic product-tracing requirements.
Authorized trading-partner requirements.
Transaction information and product-tracing obligations.
Suspect and illegitimate product requirements.
Saleable-return and verification requirements.
Product identifiers and serialization-related requirements.
Regulatory implications of drop shipments, consignments, inventory programs, and other alternative distribution arrangements.
Storage, handling, shipping, returns and recall requirements.
Regulatory implications of new products, customers, services and distribution models.
Regulatory issues arising from manufacturer/distributor relationships.
Controlled Substances and Specialized Products
Advise regarding Controlled Substances Act and DEA requirements affecting Company operations.
Address regulatory issues involving controlled-substance distribution, storage and related business activities.
Evaluate regulatory implications of new controlled products or changes in distribution models.
Advise regarding active pharmaceutical ingredients and other products presenting specialized federal or state regulatory requirements.
Analyze whether proposed products, activities or operational changes trigger additional registrations, licensing or regulatory requirements.
Coordinate with Compliance and Licensing regarding implementation of resulting registration or licensing requirements.
Operational licensing, renewals, registrations and routine licensing administration will remain with the appropriate Compliance/Licensing function.
Specialty Pharmacy Regulation
Provide regulatory legal advice regarding:
Federal and state pharmacy-law requirements.
Specialty-pharmacy operating models.
Pharmacy-practice and dispensing requirements.
Prescription-processing workflows.
Patient intake activities.
Prescription transfer requirements.
Shipping and delivery of prescription products.
Multistate pharmacy operations.
Third parties performing pharmacy-support functions.
Regulatory implications of new specialty-pharmacy products, services…