Regulatory Compliance Specialist

hace 4 días

Ciudad de México, Ciudad de México Iris Software A tiempo completo

Job Description:

We are seeking a highly skilled and experienced Senior Regulatory Compliance professional to join our Iris Software team. As a key member of our regulatory compliance team, you will be responsible for ensuring that our IT applications comply with relevant regulations and industry standards.

About the Role:

This is an exciting opportunity to work with a leading organization in the pharmaceutical industry, where you will be responsible for providing expertise on computer system validation, stakeholder management, and regulatory compliance. You will be part of a dynamic team that is passionate about delivering high-quality solutions to our clients.

Key Responsibilities:

  • Actively contribute to IT applications project management initiatives, including validation activities following the GAMP Life Cycle approach.
  • Integrate technology with business process transformation programs, such as SAP, LIMS, ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, Argus, and Regulatory Information Management System.
  • Troubleshoot IT application-related issues and provide recommendations for solutions in consultation with relevant functions.
  • Perform gap assessment and remediation procedures for legacy applications to ensure validation policies align with the Life Cycle Approach.
  • Conduct software classification, IT risk assessment, and mitigation strategies for IT applications.
  • Provide guidance and share knowledge on complex or specialized issues in a regulatory environment, working with clients to create plans for achieving engagement objectives and developing strategies that comply with professional standards and address inherent risks.
  • Assist senior managers in driving business development processes on existing client engagements by collaborating with clients and executing deliverables efficiently.
  • Create innovative insights for clients, adapting methods and practices to fit operational team needs, and contributing to thought leadership documents.
  • Demonstrate teamwork by working with cross-functional teams across service lines to complete deliverables within timelines.
  • Maintain a strong client focus by effectively serving client needs and developing productive working relationships with client personnel, staying up-to-date on current business and economic developments and new pronouncements/standards relevant to clients' businesses.
  • Review status updates and prepare management presentations.
  • Actively contribute to improving operational efficiency on projects and internal initiatives.
  • Demonstrate detailed knowledge of market trends, competitor activities, EY products, and service lines.
  • Contribute to performance feedback for staff.
  • Foster teamwork and a positive learning culture.
  • Understand and follow workplace policies and procedures.
  • Train and mentor project resources.
  • Cross-skill and cross-train team members as per business requirements.

Required Skills and Qualifications:

  • Prior experience of leading quality and compliance projects in regulatory compliance.
  • Sound domain knowledge in the pharmaceutical industry in the areas of Quality Management System - Quality control, Quality assurance.
  • Strong knowledge of Computerized Systems validation concepts such as GAMP 5 - A Risk-Based Approach to Compliant GxP Computerized Systems.
  • Hands-on experience of preparing validation deliverables for software implementation projects.
  • SOUND understanding of standards such as USFDA 21 CFR Part 11, EU GMP Annex 11.
  • Good understanding of regulations such as USFDA, WHO, HIPAA, TGA, MCC, Anvisa, etc.
  • Well-versed with ICH guidelines, ISPE framework on Risk management, and SDLC.
  • Strong Knowledge on Enterprise IT applications like LIMS, SAP, ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, Argus, Regulatory Information Management System, etc. in Pharmaceutical organization.
  • Proficient in SOP documentation, drafting work instructions/user manuals, authoring and review of Validation Deliverables such as Validation Plan & report, Requirement specifications, Risk Analysis, Qualification Protocols & reports, Test Scripts, Traceability Matrix, Data Migration strategy and report, etc.
  • Demonstrated track record in project management, governance, and reporting.
  • Good understanding of Quality System Elements such as, Deviation, CAPA, and Change Controls, etc.
  • Exposure to Data Integrity requirements and other applicable regulations.
  • Knowledge of Incident Management, Change Management, Periodic Review, Vendor Management, Quality Management Review procedures.
  • Prior experience of supporting Audits / Inspections.

Salary Range: The estimated salary range for this role is $120,000 - $180,000 per year, depending on qualifications and experience.

About Us: We are a leading organization in the pharmaceutical industry, dedicated to delivering high-quality solutions to our clients. Our team is passionate about regulatory compliance and committed to excellence in all aspects of our work.

Contact Information: For more information about this role, please contact us at [Email Address]. We look forward to hearing from you

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