
Regulatory Affairs Expert
1 day ago
Job Details
We are seeking a highly skilled Regulatory Compliance Head to join our team. This role is responsible for ensuring that all company operations, products, and processes comply with relevant regulatory requirements. This involves developing, implementing, and managing regulatory compliance programs and procedures to ensure adherence to laws, regulations, and guidelines set by regulatory bodies.
This position is critical in maintaining our organization's reputation and protecting it from GMP and regulatory compliance risks. The role ensures risks are identified, escalated, and mitigation plans are in place.
The successful candidate will have strong knowledge of QMS, GMP, and Regulatory requirements and guidelines, as well as good communication and interpersonal skills, with the ability to effectively interact with internal and external stakeholders.
- Key Responsibilities:
- Develop and execute regulatory compliance strategies and programs to ensure adherence to regulatory requirements.
- Monitor changes in the global and local regulatory environment/regulatory requirements and ensure our processes and products comply with applicable laws and regulations.
- Establish, review, and update site procedures to align with regulatory requirements.
- Represent the organization during regulatory inspections and engage with regulators, government officials, and other stakeholders.
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