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About the Role

Supports the Director of Pharmacy Services & Regulatory Affairs in ensuring Pine Pharmaceuticals’ products comply with federal and state regulatory requirements. This role combines pharmacy services and regulatory affairs responsibilities with active support of product development and commercial launch activities.

Responsibilities

• Support compliance with applicable FDA regulations and guidance documents.
• Maintain facility state and federal licenses in active good standing.
• Support compliance with DEA and state controlled substance requirements.
• Support product development and commercial launch activities.
• Generate, review, and approve product labeling.
• Review and approve marketing, advertising, and promotional materials for regulatory compliance.
• Ensure all work is accurate, precise, and properly documented and conducted within cGMP requirements.
• 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.
• Perform other duties as needed by the company.

Requirements

• 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.

Skills

• Working knowledge of pharmacy law, cGMP, FDA labeling and 503B requirements, and applicable USP compendial standards.
• Strong attention to detail and accuracy.
• Organized; able to multi-task and prioritize.
• Excellent written and verbal communication skills.
• Able to work in a dynamic, changing environment and collaborate effectively in cross-functional teams.

Location

• On-site

Work Type

• Full-time

Experience Level

• Two or more years of experience

Education Level

• PharmD

About the Company

• Pine Pharmaceuticals’ products are developed, tested, manufactured, marketed, and distributed in compliance with applicable federal and state regulatory requirements.