Regulatory Affairs Consultant – Compliance & Process (hybrid)

When our values align theres no limit to what we can achieve.

At Parexel we all share the same goal - to improve the worlds health. From clinical trials to regulatory consulting and market access every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us no matter what we do at Parexel contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally we do it with empathy and were committed to making a difference.

We are seeking a highly collaborativeRegulatory Affairs Consultant Compliance & Processto strengthen global regulatory compliance and quality operations across GxP environments. You will partner with Regulatory Affairs Quality CMC Clinical Operations and other cross-functional teams to enable compliant efficient and scalable business operations.

This is a client dedicated project and the role requires to be in the Warsaw office (hybrid model).

Key Responsibilities

Controlled Document Management & Governance

• 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

Training Governance & Compliance

• 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

• Support inspection readiness activities related to training documentation and personnel qualification

Regulatory Compliance & Inspection Readiness

• 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

Quality Systems & Operational Excellence

• 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

Skills and Experience required for the role:

• Bachelors 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