Regulatory Specialist
The Regulatory Specialist is accountable for ensuring the organization meets all VAWD, DEA, and FDA compliance requirements, including oversight of distribution licensing. The role encompasses diverse regulatory duties needed to uphold compliance with federal, state, and industry regulations.
Key Responsibilities:
- Administer and oversee all FDA, DEA, and State Board of Pharmacy licensing activities.
- Manage, track, and renew required licenses across all organizational subsidiaries.
- Support the company's suspicious order monitoring program and related compliance activities.
- Collaborate with operations to develop, refine, and implement process improvements in response to audit results and changing regulatory requirements.
- Ensure warehouse operations meet readiness standards for federal, state, and industry audits or inspections.
- Develop the annual licensing budget and perform ongoing variance analyses, reporting, and reconciliation.
- Provide backup regulatory support for activities related to mergers, acquisitions, and corporate integrations.
- Conduct routine internal audits in alignment with the company's compliance policies and Quality System requirements.
- Lead and manage all phases of the NABP application, accreditation, and renewal cycle.
- Draft, update, and maintain procedural documentation and work instructions for NABP accreditation activities.
- Partner with operations to provide licensing timelines, cost projections, and facility requirements based on intended distribution and shipping models.
- Perform corporate-wide audits as part of the established compliance program.
Qualifications:
- Bachelor's degree required.
- 2-5 years of regulatory or quality experience within the medical device or pharmaceutical industry.
- Prior direct experience in medical device or pharmaceutical regulatory functions strongly preferred.
- Strong working knowledge of FDA, DEA, and state regulatory requirements, as well as practical experience applying Quality Systems to support compliance.
- Excellent communication and interpersonal skills, with the ability to effectively engage internal teams and external regulatory agencies.
FAQs
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