Regulatory Affairs Consultant – Compliance & Process

This is a fully remote position, open to applicants in United Kingdom, +7 more countries.

📋 Description

• Act as a Subject Matter Expert (SME) for the management of controlled documents, ensuring adherence to compliance standards and readiness for inspections.

• Draft, assess, authorize, and oversee controlled procedures and quality documents in accordance with GxP standards.

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

• Offer expertise on procedural writing guidelines and best practices for document management.

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

• Sustain effective training programs that correspond with role-specific duties and document modifications.

• Track training compliance metrics and aid in the resolution of non-compliant records.

• Facilitate readiness for inspections concerning training documentation and staff qualifications.

• Spearhead regulatory compliance efforts across global GxP operations.

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

• Keep abreast of changing regulatory requirements and implement strategies for compliance.

• Aid in the formulation of remediation plans addressing audit findings and compliance deficiencies.

• Oversee Quality Management System (QMS) processes, including deviations, 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.

• Collaborate with Regulatory Affairs, Quality, CMC, Clinical Operations, and other cross-functional teams to facilitate compliant, efficient, and scalable business operations.

⛳️ Requirements

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

• Over 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.

• Excellent analytical, communication, and stakeholder management abilities.

• Capacity to juggle multiple priorities in a fast-paced environment.

• Experience in supporting global compliance initiatives across various regions.

• Knowledge of Veeva Vault is a plus.

• Proficient in English, both written and spoken.

🏝️ Benefits

• Competitive salary and performance-based bonuses.

• Comprehensive health and wellness programs.

• Opportunities for professional development and career advancement.

• Flexible working hours and potential for remote work options.

• Collaborative and inclusive work environment.