Regulatory Affairs Consultant – Compliance, Process

This is a fully remote position, open to applicants in Romania.

📋 Description

• Act as the Subject Matter Expert (SME) for controlled document management, ensuring adherence to governance standards and readiness for inspections.

• Draft, review, approve, and oversee controlled procedures and quality documents in accordance with GxP standards.

• Lead document lifecycle management activities, including the creation, revision, periodic review, and archival processes.

• Offer guidance on procedural writing standards and best practices for document management.

• Assist in GxP training governance to guarantee compliance with regulatory mandates.

• Maintain effective training curricula that align with role-specific responsibilities and updates to procedures.

• Track training compliance metrics and facilitate the remediation of any non-compliant records.

• Oversee regulatory compliance efforts across global GxP operations.

• Propel initiatives aimed at inspection readiness and support inspections from FDA, EMA, MHRA, and other health authorities.

• Keep abreast of evolving regulatory requirements and implement appropriate compliance strategies.

• Aid in the development of remediation plans to address audit findings and compliance deficiencies.

• Manage Quality Management System (QMS) processes, including deviations, Corrective and Preventive Actions (CAPAs), change controls, SOP management, and document control.

• Leverage metrics and trend analysis to pinpoint compliance risks and promote continuous improvement.

• Support the harmonization of quality processes to enhance scalability and effectiveness.

⛳️ Requirements

• A Bachelor's degree in Life Sciences, Pharmacy, Biotechnology, Engineering, or a related field.

• A minimum of 8 years of experience in Regulatory Compliance, Quality Assurance, or related GxP functions within the pharmaceutical or biotechnology sectors.

• In-depth knowledge of FDA, EMA, ICH, and global GxP regulations.

• Proven experience in supporting regulatory inspections and managing audits.

• Practical experience with controlled document management and electronic Document Management Systems (eDMS).

• Familiarity with GxP training governance and learning management systems.

• Strong analytical, communication, and stakeholder management abilities.

• Capability to handle multiple priorities in fast-paced environments.

• Experience in biologics, vaccines, or advanced therapeutics is preferred.

• Background in supporting global compliance initiatives across various regions.

• Knowledge of Veeva Vault is a plus.

• Proficient in English, both written and spoken.

🏝️ Benefits

• Governance of GxP training.

• Monitoring of training compliance metrics.

• Management of Quality Management System (QMS) processes.