How do you handle situations where there is a conflict between regulatory requirements and company policies?

When faced with a conflict between regulatory requirements and company policies, I believe it is essential to first understand the underlying reasons for each requirement. I would carefully review the specific regulations and policies involved, paying close attention to any nuances. Then, I would seek guidance from the appropriate stakeholders, such as regulatory affairs, legal, and compliance departments, to gain a comprehensive understanding of the implications of both sides. In this way, I can assess the potential risks and impact on the company. I would document all the relevant information and engage in open and transparent communication with the stakeholders to find a resolution that balances both regulatory compliance and company policies.

In my previous role as a Clinical QA Specialist, I encountered a situation where there was a conflict between a regulatory requirement and a company policy. The regulatory requirement stated that all adverse events should be reported to the regulatory agency within 24 hours, while the company policy required internal review and investigation before submitting the report. To resolve this conflict, I first conducted a thorough analysis of the specific regulations and company policies involved. I consulted with the regulatory affairs team to understand the consequences of non-compliance and the potential risks for the company. Simultaneously, I engaged in open communication with the internal stakeholders, including the safety team, to discuss the potential impact of immediate reporting versus the importance of internal review. Through effective communication and negotiation, we reached a compromise that involved implementing an expedited internal review process, allowing us to meet both the regulatory requirement and the company policy. This experience highlighted my ability to navigate complex situations and find practical solutions that balance regulatory compliance and company policies.

During my tenure as a Clinical QA Auditor at XYZ Pharmaceuticals, I encountered a conflict between a substantial regulatory requirement and a long-standing company policy. The regulatory agency mandated a modification to the informed consent process, requiring explicit consent from participants for certain study procedures. However, the company policy, based on years of successful participation and consent practices, emphasized using a streamlined approach to reduce participant burden and promote retention. To address this conflict, I initiated a comprehensive review of the regulatory guidance, consulting with ethics committees and external experts to gain additional insights. Simultaneously, I collaborated with internal stakeholders, including legal, compliance, and senior management, to understand the potential legal and reputational risks of non-compliance. The conflict resolution involved creating a hybrid consent process that incorporated the regulatory requirement without compromising participant engagement and retention. This solution received approval from the regulatory agency, and it was recognized as a best practice within our organization. This experience showcased my ability to navigate complex regulatory landscapes, engage stakeholders effectively, and find innovative solutions that align with both regulatory requirements and company policies, while maintaining the highest ethical standards.