Sr. Regulatory Specialist
About The Position
At Safecor Health, our mission is simple but powerful: help hospitals and healthcare providers deliver medications to patients safely, efficiently, and reliably. As the nation’s largest independently owned medication repackaging company, Safecor Health supports hospitals and long-term care facilities across the country by providing unit-dose medications that improve patient safety and streamline pharmacy operations. From our facilities in Columbus, Ohio; Rockford, Illinois; and Woburn, Massachusetts, our teams repackage oral solids, liquids, and other medications used in hospital automation systems. Behind every product we deliver is a team committed to our core values: Care. Commitment. Excellence. We are currently seeking a Senior Regulatory Specialist to join our Quality team and help ensure the regulatory integrity and compliance that hospitals rely on. The Opportunity The Senior Regulatory Specialist plays a key role in supporting Safecor Health’s regulatory and quality systems to ensure compliance with FDA, DEA, and state regulatory requirements. This position partners closely with Quality, Operations, and Regulatory leadership to support inspections, documentation systems, and continuous improvement initiatives that strengthen our compliance programs. This is an excellent opportunity for a regulatory professional who enjoys working cross-functionally, solving complex quality challenges, and helping maintain the high standards required in pharmaceutical manufacturing.
Requirements
- Bachelor’s degree in Chemistry, Life Sciences, or related field (or equivalent experience)
- 3–5 years of pharmaceutical or regulated industry experience, preferably in regulatory or quality roles
- Experience with FDA requirements and cGMP regulations
- Experience supporting quality systems, inspections, audits, or regulatory documentation
- Strong understanding of FDA expectations, cGMP practices, and ICH guidelines
- Strong documentation and organizational skills
- Excellent attention to detail and procedural compliance
- Effective written and verbal communication skills
- Ability to work both independently and collaboratively
Nice To Haves
- Experience with stability programs, investigations, or laboratory operations preferred
- DEA regulatory experience is a plus
- Experience with HPLC, GC, or laboratory analytical equipment
- Experience with quality management systems; MasterControl experience preferred
Responsibilities
- Regulatory & Compliance Support Support the maintenance of FDA-compliant Quality Systems in accordance with 21 CFR Parts 210 & 211 and FDA guidance
- Assist in the preparation and execution of internal and external regulatory audits
- Perform facility inspections to ensure adherence to SOPs and cGMP requirements
- Assist with state licensing documentation and regulatory submissions
- Support responses to regulatory inspection observations
- Quality Systems & Documentation Draft, review, and maintain SOPs, forms, and work instructions
- Maintain training records, change control documentation, and quality documentation systems
- Assist with Annual Product Reviews (APRs)
- Support Commercial Batch Record issuance, review, and release
- Quality Investigations & Continuous Improvement Assist in documenting and tracking deviations, incidents, CAPAs, and customer complaints
- Monitor quality metrics and compile data to identify trends
- Collaborate with Operations and Quality teams to implement corrective and preventive actions
- Participate in process improvement initiatives to strengthen compliance and efficiency
- Regulatory & Licensing Support Maintain records required for state licensing and regulatory reporting
- Support DEA and FDA compliance activities under Regulatory leadership
- Maintain supplier documentation within MasterControl
- Quality Operations & Laboratory Support Support stability studies and testing programs, including protocol coordination and documentation
- Assist with SLIMS (Stability LIMS) management
- Support sampling, sample retention, and label control processes
- Assist with quality checks and batch releases
- Facilities & Equipment Oversight Support quality oversight of temperature monitoring, water systems, and equipment calibration
- Maintain equipment and compliance documentation within ERP quality systems
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
