Position Summary
The Pharmacist - Pharmacy Services/Regulatory Affairs supports the Director of Pharmacy Services & Regulatory Affairs in ensuring that Pine Pharmaceuticals' products are developed, tested, manufactured, marketed, and distributed in compliance with applicable federal and state regulatory requirements. This role combines pharmacy services and regulatory affairs responsibilities (including label generation, controlled substance oversight, state and federal licensure and applications, and marketing and promotional approvals) with active support of product development and commercial launch activities. The position requires a working knowledge of pharmaceutical sciences, ability to interpret applicable laws and regulations, and USP compendial standards.
Position is on-site, 40hrs/week.
Essential Functions:
- Regulatory compliance: Support compliance with applicable FDA regulations and guidance documents, including the 503B Bulks List, Drug Shortage List, and Compounded Product Reporting.
- Licensure and applications: 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.
- Controlled substances: 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).
- Product development and launch: 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.
- Label generation: Generate, review, and approve product labeling, including container, carton, and packaging labels, to ensure accuracy and compliance with FDA labeling requirements and internal specifications.
- Marketing approvals: Review and approve marketing, advertising, and promotional materials for regulatory compliance prior to release.
- Quality and documentation: 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.
- Customer complaints and ADE reporting: 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.
- Other duties as needed by the company.
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
