Pharmacist - Pharmacy Services/Regulatory Affairs

Position Summary

The Pharmacist - Pharmacy Services/Regulatory Affairs supports the Director of Pharmacy Services & Regulatory Affairs in ensuring Pine Pharmaceuticals’ products comply with federal and state regulatory requirements. This role integrates pharmacy services and regulatory affairs responsibilities, including label generation, controlled substance oversight, state and federal licensure and applications, and marketing and promotional approvals.

Essential Functions

• Support compliance with applicable FDA regulations and guidance documents, such as the 503B Bulks List, Drug Shortage List, and Compounded Product Reporting.

• Maintain facility state and federal licenses in active good standing; prepare and submit license applications, registrations, renewals, and supporting documentation.

• Maintain individual pharmacist licensure and support pharmacist presence requirements across applicable states.

• Support compliance with DEA and state controlled substance requirements, including recordkeeping, inventory oversight, ordering and distribution documentation, and required reporting (e.g., DEA/ARCOS and state controlled substance reporting).

• Support product development and commercial launch activities, including process and formulation development, protocol design and execution, and engineering runs; participate in the development of project timelines and tracking of deliverables; and identify and help resolve technical, resource, or scheduling constraints with internal teams and external vendors.

• Generate, review, and approve product labeling, including container, carton, and packaging labels, to ensure accuracy and compliance with FDA labeling requirements and internal specifications.

• Review and approve marketing, advertising, and promotional materials for regulatory compliance prior to release.

• Ensure all work is accurate, precise, and properly documented and conducted within cGMP requirements; collaborate with Quality Control and Quality Assurance to maintain adherence to quality standards.

• Support the customer complaint program and adverse drug event (ADE) reporting.

• Provide cross-functional support and project management for CAPAs and other process improvement efforts.

Education And Experience

• PharmD required.

• Active New York State Pharmacist license required, in good standing.

• Two or more years of pharmacy experience; experience in a 503B outsourcing facility, regulatory affairs, or pharmaceutical product development preferred.

• Familiarity with FDA regulatory requirements and guidance governing pharmaceutical product development, labeling, and 503B outsourcing facilities; working knowledge of DEA and state controlled substance regulations preferred.

Knowledge, Skills And Abilities

• Working knowledge of pharmacy law, cGMP, FDA labeling and 503B requirements, and applicable USP compendial standards.

• Strong attention to detail and accuracy, with high standards for documentation.

• Organized; able to multi-task and prioritize across daily demands while managing long-term projects.

• Excellent written and verbal communication skills.

• Able to work in a dynamic, changing environment and collaborate effectively in cross-functional teams.

Physical Requirements / Working Conditions

• Ability to lift up to 30 lbs.

• Work is performed in an office and controlled manufacturing/cleanroom environment.

Compensation

$125,000.00 - $135,000.00 annually.