Regulatory Compliance Lead - DEA & State Licensing

Perrigo•Allegan Township, MI

1d•Hybrid

About The Position

The Regulatory Compliance Lead is responsible for maintaining compliance with DEA regulations and state licensing requirements across multiple jurisdictions. This role supports manufacturing and distribution of regulated products by managing quota activities, maintaining licenses, leading inspections, and ensuring timely regulatory submissions. The position develops and applies subject matter expertise in DEA and state licensing compliance and partners across Regulatory Affairs, Supply Chain, Quality, and Operations to support uninterrupted supply and regulatory compliance.

Requirements

Bachelor's degree in Life Sciences, Regulatory Affairs, Business, Supply Chain, Quality, Operations, Engineering, or a related field; equivalent combination of education and relevant experience may be considered.
Experience coordinating compliance, quality, regulatory, supply chain, manufacturing, operations, auditing, or documentation-related activities in a regulated environment.
Ability to interpret and apply regulations, standards, policies, or business requirements to operational processes and decision-making.
Strong organizational and project coordination skills with the ability to manage multiple priorities and deadlines.
Proficiency in Microsoft Excel and experience working with data, reporting, tracking tools, or enterprise systems (e.g., SAP or similar platforms).
Strong written and verbal communication skills with the ability to collaborate across functions and interact with external stakeholders.

Responsibilities

Coordinate DEA-controlled substance compliance activities, including quota requests, reconciliation reporting, and regulatory submissions.
Maintain DEA registrations and state licenses, including renewals, new applications, and cancellations.
Prepare, review, and submit regulatory filings accurately and on time.
Serve as contact with DEA and Boards of Pharmacy; coordinate responses to regulatory inquiries.
Lead and support inspections; ensure audit readiness and successful outcomes.
Collaborate with Supply Chain, Procurement, R&D, Quality, and Operations to support regulated product supply.
Provide regulatory guidance and training to internal stakeholders.
Drive process improvements and develop SOPs and compliance documentation.