Regulatory Affairs Supervisor

Position Summary:

The Supervisor, Regulatory Affairs is responsible for leading regulatory compliance activities and supporting the Quality Management System (QMS) to ensure operations remain compliant with applicable federal, state, and international regulatory requirements. This role interprets and operationalized regulatory expectations across GMP operations. The position provides regulatory leadership while performing Quality Assurance functions necessary to support daily operations and supervises Regulatory Affairs personnel.

Duties & Responsibilities:

1. Interpret and apply applicable regulations, guidance documents, and industry standards from regulatory authorities including, but not limited to:
2. Food and Drug Administration (FDA), State Boards of Pharmacy, National Association of Boards of Pharmacy (NABP), Drug Enforcement Administration (DEA), U.S. Customs and Border Protection (CBP), & Other international regulatory authorities as applicable.
3. Monitor regulatory developments, emerging guidance, and enforcement trends; assess impact on company operations and communicate requirements to leadership.
4. Maintain regulatory intelligence and ensure internal procedures remain aligned with current regulatory expectations.
5. Support regulatory registrations, licenses, and renewals required for company operations.
6. Collaborate closely with Sentry Legal to strengthen the organization’s understanding of regulatory compliance and legal obligations.
7. Author, review, and/or approve GMP and non-GMP records (preventative maintenance, pest control, facility walk throughs, etc.).
8. Author, drive implementation, and check the effectiveness of CAPAs. Track open CAPAs, ensuring timely completion, and/or requesting for extensions as applicable.
9. Author deviation and investigation reports related to quality system failures, perform Root Cause Analysis (RCA), perform required Client notifications, and evaluate impact to SISPQ. Track all open deviations, ensuring timely completion, and/or requesting extensions as applicable.
10. Perform Quality oversight of Warehouse/Operations which includes:
11. Food and Drug Administration (FDA), State Boards of Pharmacy, National Association of Boards of Pharmacy (NABP), Drug Enforcement Administration (DEA), U.S. Customs and Border Protection (CBP), & Other international regulatory authorities as applicable.
12. Coordinating appropriate QA coverage for routine verification of receipts and shipments.11
13. Monitoring incoming client orders (inbound and outbound) for errors and interfacing with Sentry clients for corrections (non-conformance notice), as needed.
14. General Quality duties in Warehouse Management System (status changes, expiration date changes, approving new items, etc.).
15. Support Manufacturing Operations. This includes but is not limited to:
16. Perform/Review internal material releases on labels, drug products, etc., assist with batch record development, execution, or review, Act as a performer or verifier for labeling and packaging operations, perform statistical QA verification of labeled and packaged products, perform line clearance activities of labeling room as necessary, and provide quality oversight over internal/external validation and calibration activities and documentation in compliance with Sentry’s Validation Master Plan, SOPs, and applicable regulations.
17. Assist in maintaining the supplier qualification program. This includes but is not limited to: Tracking the status of all supplier qualifications and ensuring requalification’s are performed on time, performing paper audits of all necessary suppliers and ensuring all necessary records are on file, perform physical audits of suppliers.
18. Support and/or host internal, Client, and regulatory audits/inspections.
19. Assist in the development and reporting of quality metrics and preparation of the management review agenda.
20. Provide training to staff on quality-related procedures and standards to ensure a consistent understanding of quality requirements.
21. Assist in training new Quality Assurance and Regulatory Affairs staff.
22. Additional duties as assigned by leadership.

Competencies:

• Self-motivated with minimal need for supervision.
• Ability to multi-task and manage time effectively under pressure.
• Effective time management.
• Excellent attendance and punctuality.
• Detail-oriented with strong organizational skills.
• In-depth knowledge of GMP regulations and reporting requirements.
• Commitment to continuous improvement and adaptability to change.
• Understanding of job functions and their relation to other roles within the organization.
• Excellent verbal and written communication skills, with the ability to develop rapport at all organizational levels.
• Results-driven with personal initiative and perseverance.
• Excellent teamwork and collaboration skills.

Education and/or experience:

Required: BA or BS in a science/technical field and five (5) years of QA/QC experience in a pharmaceutical, biotech, medical device, or other FDA-regulated industry.

Computer Skills:

To perform this job successfully, an individual should have proficient knowledge of Microsoft Office (Word, Excel, Outlook), web browsers, barcoding systems, electronic Quality Management Systems (eQMS), and quick ability to learn new software.