Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

The Senior Regulatory Compliance Specialist is responsible for leading and managing regulatory compliance activities with a strong focus on health authority and client audits. This role ensures that audit observations are effectively addressed, corrective and preventive actions (CAPAs) are robust and sustainable, and compliance with applicable regulations and standards is continuously maintained.

Key Responsibilities

Audit Management

• Lead the planning, coordination, and execution of health authority inspections (e.g., FDA, EMA, MHRA) and client audits.
• Serve as the primary point of contact during audits, ensuring timely and accurate communication with auditors.
• Prepare audit-ready documentation and ensure site/functional readiness through routine assessments and mock audits.

Audit Response & Remediation

• Oversee the review, classification, and response to audit observations, ensuring clarity, accuracy, and regulatory alignment.
• Partner with cross-functional teams to develop comprehensive responses that address root causes.
• Ensure timely submission of audit responses and commitments to regulatory authorities and clients.

CAPA Management & Effectiveness

• Lead CAPA development, ensuring root cause analyses are thorough and scientifically sound.
• Review and approve CAPA plans for adequacy, feasibility, and compliance risk mitigation.
• Monitor CAPA implementation and verify effectiveness through appropriate metrics, trending, and follow-up activities.
• Drive continuous improvement of CAPA processes to enhance compliance and operational performance.

Regulatory Compliance Oversight

• Ensure ongoing compliance with applicable regulations (e.g., GMP, GLP, GCP as applicable) and internal quality systems.
• Interpret regulatory requirements and translate them into actionable procedures and controls.
• Support regulatory inspections and internal audits by providing subject matter expertise.

Cross-Functional Collaboration

• Collaborate with Quality, Operations, Regulatory Affairs, and other stakeholders to ensure alignment on compliance strategies.
• Provide guidance and training to teams on audit readiness, inspection conduct, and CAPA best practices.

Metrics & Reporting

• Track, trend, and report audit findings, CAPA status, and compliance metrics to senior management.
• Identify systemic issues and drive proactive improvements to reduce compliance risk.

REQUIREMENTS:
• Advanced Degree plus 6 years of experience, or Bachelor's Degree plus 8 years of experience in compliance, quality systems, or regulatory affairs
• Professional certifications in Quality Systems, Regulatory Compliance or others
• Expertise in quality management systems and regulatory standards (ISO, GMP, FDA)
• Experience with compliance management software (Veeva, MasterControl, trackwise)
• Proven ability to develop and implement standard operating procedures (SOPs)
• Strong project management and risk assessment capabilities
• Effective stakeholder management and cross-functional collaboration skills
• Advanced problem-solving and analytical skills
• Strong written and verbal communication abilities
• Demonstrated ability to lead internal/external audits
• Proficiency in Microsoft Office Suite and relevant compliance tools
• Strong attention to detail and ability to maintain accurate records
• Ability to work independently while contributing to team objectives
• Travel may be required