Sr. Regulatory Specialist

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.

How You Will Make an Impact

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 observationsQuality 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 releaseQuality 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 efficiencyRegulatory & Licensing Support

Maintain records required for state licensing and regulatory reporting

Support DEA and FDA compliance activities under Regulatory leadership

Maintain supplier documentation within MasterControlQuality 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 releasesFacilities & Equipment Oversight

Support quality oversight of temperature monitoring, water systems, and equipment calibration

Maintain equipment and compliance documentation within ERP quality systems

What You Bring

Education & Experience

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

Experience with stability programs, investigations, or laboratory operations preferred

DEA regulatory experience is a plusKnowledge, Skills & Abilities

Strong understanding of FDA expectations, cGMP practices, and ICH guidelines

Experience with HPLC, GC, or laboratory analytical equipment

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

Experience with quality management systems; MasterControl experience preferredWhy Join Safecor Health?

At Safecor Health, you'll join a team that plays a direct role in improving medication safety for hospitals across the country. Our employees are trusted experts who take pride in doing meaningful work in a highly regulated environment.

If you're passionate about regulatory excellence, quality systems, and ensuring compliance in pharmaceutical operations, we'd love to hear from you.