Regulatory Affairs Consultant – Compliance, Process
Employment Information
Report this job
Job expired or something wrong with this job?
Job Description
Regulatory Affairs Consultant focusing on compliance and quality operations in GxP environments for Parexel. Collaborating with cross-functional teams to deliver compliant and efficient business operations.
Responsibilities:
- Serve as SME for controlled document management, ensuring compliant governance and inspection readiness
- Author, review, approve, and manage controlled procedures and quality documents per GxP requirements
- Drive document lifecycle management activities including creation, revision, periodic review, and archival
- Provide guidance on procedural writing standards and document management best practices
- Support GxP training governance to ensure compliance with regulatory requirements
- Maintain effective training curricula aligned with role-based responsibilities and procedural updates
- Monitor training compliance metrics and support remediation of non-compliant records
- Lead regulatory compliance activities across global GxP operations
- Drive inspection readiness initiatives and support FDA, EMA, MHRA, and other health authority inspections
- Monitor evolving regulatory requirements and implement compliance strategies
- Support development of remediation plans for audit findings and compliance gaps
- Manage QMS processes including deviations, CAPAs, change controls, SOP management, and document control
- Utilize metrics and trend analysis to identify compliance risks and drive continuous improvement
- Support harmonization of quality processes to improve scalability and effectiveness
Requirements:
- Bachelor's degree in Life Sciences, Pharmacy, Biotechnology, Engineering, or related field
- 8+ years in Regulatory Compliance, Quality Assurance, or related GxP functions in pharma/biotech
- Strong knowledge of FDA, EMA, ICH, and global GxP regulations
- Experience supporting regulatory inspections and audit management
- Hands-on experience with controlled document management and eDMS platforms
- Experience with GxP training governance and learning management systems
- Strong analytical, communication, and stakeholder management skills
- Ability to manage multiple priorities in fast-paced environments
- Experience in biologics, vaccines, or advanced therapeutics (preferred)
- Experience supporting global compliance initiatives across multiple regions
- Familiarity with Veeva Vault
- Fluent in English written and spoken
Benefits:
- GxP training governance
- Training compliance metrics monitoring
- Quality Management System (QMS) processes management
Similar Jobs
Senior Vice President, Technical - Clinical Regulatory Affairs
Senior/Vice President, Technical overseeing regulatory strategies for biopharma clinical development. Work from home position with significant impact on patient therapeutic developments.
Governance & Compliance Specialist
Governance & Compliance Specialist driving transformation programs within GRC frameworks for a multinational consulting firm. Operate governance frameworks, manage risks, and support compliance in a fully remote role.
Governance & Compliance Specialist
Governance & Compliance Specialist ensuring delivery within GRC frameworks at fast-growing consulting firm. Responsible for steering transformation and transition programs while maintaining compliance and risk management.
Regional Food Safety Quality Regulatory Lead
Regional Food Safety Quality Regulatory POD Lead providing leadership and compliance for Cargill plants. Partnering with stakeholders for strategy alignment, continuous improvement, and regulatory adherence.
Regulatory Operations Documentation Specialist
Support Regulatory Operations with electronic submission documentation. Focus on document formatting, quality control, and communication archiving with Health Authorities.
Compliance Analyst I, Licensing
Compliance Analyst ensuring Guild Mortgage Company adheres to legal regulations. Supporting compliance management and maintaining licenses with state and federal agencies.
Compliance EDD & High Risk Client Team Lead
Team Lead overseeing Compliance EDD & High Risk Client activities. Leading a compliance team while ensuring timely resolutions for high-risk cases in international crypto operations.
Director, Personal Trading & Compliance
Director of Personal Trading and Compliance at Empower leading compliance efforts and managing a high-performing team. Ensuring regulatory adherence and promoting ethical conduct across the organization.
Senior Compliance Specialist
Sr Compliance Specialist at General Motors Insurance managing legal processes and ensuring compliance with regulations. Collaborating closely on corporate governance and legal operations.
Regulatory and Start Up Specialist
Regulatory and Start Up Specialist in clinical research managing site activation and ensuring compliance with regulations. Collaborating across teams and preparing essential regulatory documents.
Regulatory Labeling Manager
Regulatory Labeling Manager overseeing labeling content for lifecycle pharmaceutical products. Collaborating with stakeholders to ensure compliance with regulatory requirements and governance processes.
Senior Regulatory Affairs Specialist
Senior Regulatory Specialist responsible for planning and executing regulatory projects for medical devices at Medline. Ensuring compliance with FDA regulations and managing product submissions.
Assurance Compliance Officer
Assurance Compliance Officer ensuring compliance within Coastal Community Bank's operations. Responsible for monitoring and testing compliance with banking regulations and building relationships with key stakeholders.
Junior IT, Compliance Engineer
Junior IT & Compliance Engineer at Velora, a remote-first company supporting nonprofits with integrated systems. Handle IT requests and assist in compliance tasks across various programs.
ISO Compliance Specialist
ISO Compliance Specialist managing regulatory compliance for various U.S. ISO/RTOs. Ensuring adherence to ERCOT and other regulatory frameworks with a focus on compliance strategies and reporting.
Senior Analyst, Global Trade Compliance
Senior Analyst supporting trade compliance programs across EMEA at Illumina. Collaborating with teams to ensure adherence to customs and trade regulations.
IT Compliance Analyst
Analista de Compliance de TI focado em validação de controles e aplicação de padrões de compliance da PwC. Atuando em projetos em mais de 21 países com responsabilidades em auditorias e gestão de riscos.
Process Risk and Compliance Operations Manager
Process Risk and Compliance Operations Manager at Airbnb, owning risk frameworks and evolving risk strategies. Collaborating with investigations to ensure robust risk governance.
Senior Executive, Compliance
Senior Executive in Quality Compliance ensuring Contract Manufacturing Organizations meet pharmaceutical standards and best practices. Collaborating with regulatory bodies to uphold compliance and quality assurance processes.
Privacy Compliance Consultant – Children’s Data Compliance
Privacy Compliance Consultant evaluating children's data compliance regulations for digital products, focusing on privacy assessments of websites, apps, and platforms.