Regulatory Affairs Pharmacist

Indiana Hemophilia & Thrombosis Center•Indianapolis, IN

2d•Onsite

About The Position

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. 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.

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.
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.

Nice To Haves

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.
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.
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.
An equivalent combination of education, pharmacy practice experience, and regulatory or accreditation leadership experience may be considered.

Responsibilities

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.