Regulatory Affairs Pharmacist

About IHI

At Innovative Hematology, Inc. (IHI), we offer a future where people with rare blood disorders flourish. Our experts provide the highest quality comprehensive services and holistic care to patients with bleeding, clotting and other hematologic disorders, and to their families.

What You Will Do

As the Regulatory Affairs Pharmacist, you will oversee regulatory compliance, accreditation readiness, and pharmacy licensing across current and future states of operation. In this role you will develop scalable compliance practices, support audits and inspections, partners with operational and clinical leaders, and allocate up to 20% of work time to Specialty Dispensing Pharmacist responsibilities.

The Opportunity

• Oversees pharmacy facility licensing, nonresident permits, controlled substance registrations, and related renewals across current and future states of operation.
• Develops and maintains scalable licensing strategies that support organizational growth, acquisitions, new pharmacy services, and external partnerships.
• Monitors federal, state, and local pharmacy requirements and communicate operational impacts to leadership and affected teams.
• Ensures compliance with DEA and state-controlled substance requirements and support the licensing lifecycle for personnel, facilities, and distribution activities.
• Leads accreditation readiness for pharmacy service lines, including specialty, retail, and infusion, and support standards associated with URAC, ACHC, The Joint Commission, NABP, and other applicable bodies.
• Coordinates mock surveys, internal audits, external audits, corrective action plans, staff education, and continuous improvement activities.
• Develop, review, and maintain pharmacy policies and procedures aligned with multistate regulatory, accreditation, 340B, payer, contract pharmacy, and partnership requirements.
• Partners with Legal, Compliance, Quality, clinical teams, and pharmacy operations to promote consistent regulatory interpretation and enterprise alignment.
• Serves as a primary pharmacy contact for Boards of Pharmacy, accreditation organizations, inspectors, auditors, and other regulatory stakeholders as assigned.
• Maintains organized documentation, evidence files, renewal calendars, survey materials, and leadership reporting for licensing and accreditation activities.
• Allocates up to 20% of work time to prescription verification, clinical review, patient counseling, adherence and safety monitoring, and operational workflow coverage for specialty medications.
• Ensures dispensing activities comply with REMS, limited distribution drug, payer, and other medication-specific requirements, and collaborate with providers and care teams to optimize therapy outcomes.

Knowledge:

• Knowledge of federal and multistate pharmacy laws, licensing requirements, controlled substance regulations, and standards of pharmacy practice.
• Knowledge of specialty pharmacy accreditation principles, audit readiness, quality management, 340B requirements, and corrective action processes.
• Knowledge of specialty medication dispensing, patient counseling, medication safety, REMS, payer requirements, and limited distribution networks.
• Knowledge of policy governance, document control, and compliance monitoring methods.

Skills:

• Skill in regulatory research, interpretation, policy writing, project management, audit preparation, and risk assessment.
• Skills in leadership, staff education, cross-functional collaboration, stakeholder communication, and change management.
• Skill in organizing complex multistate requirements, renewal schedules, evidence files, and competing priorities.
• Skill in using pharmacy systems, Microsoft Office applications, and compliance tracking tools

Abilities:

• Ability to translate regulatory and accreditation requirements into practical, sustainable pharmacy workflows.
• Ability to lead multiple initiatives, meet deadlines, maintain attention to detail, and exercise sound professional judgment.
• Ability to communicate effectively with patients, staff, auditors, regulators, accreditation bodies, providers, and senior leaders.
• Ability to perform pharmacist dispensing and clinical responsibilities safely and accurately while balancing leadership duties.

Requirements

• Doctor of Pharmacy (PharmD) or Bachelor of Science in Pharmacy from an accredited school of pharmacy.
• Minimum ten years of pharmacy experience, including regulatory, accreditation, compliance, or operational leadership experience. Experience supporting external partnerships or healthcare collaborations preferred.
• Alternative to Minimum: An equivalent combination of education, pharmacy practice experience, and regulatory or accreditation leadership experience may be considered.
• Active, unrestricted pharmacist license in Indiana. Ability to obtain and maintain additional state pharmacist licenses as required. Must maintain all continuing education, credentialing, and registration requirements applicable to the role.
• All IHI employees are expected to enable multi-factor authentication via their personal smart phone/smart device in order to access IHI systems as a requirement of the role.

This position is open to residents of the State of Indiana, and requires routine presence at our Center in Indianapolis, IN. Frequency of on-site presence is dependent upon role and department needs.

Benefits

Why join our team?

IHI is a not-for-profit program based in Indianapolis and offers a competitive salary and benefit package.

IHI is the only federally designated comprehensive hemophilia program in Indiana and serves the entire state through services available in Indianapolis and at outreach clinics.

IHI is a leader in hemophilia care, education and clinical research and has a dedicated on-site multidisciplinary staff to ensure availability of a wide range of required services.

IHI participates in national and international clinical research, including new infusion products and therapies, investigation of long-term outcomes, and the impact of associated conditions. The IHTC research program provides patients access to new therapies, and an opportunity to improve care. Our center has more than 50 clinical research projects involving bleeding disorders, sickle cell disease, thrombosis and more.