
Regulatory Compliance Specialist
19 hours ago
Job Summary
The Regulatory Compliance Head is responsible for ensuring all company operations, products, and processes comply with relevant regulatory requirements. This role involves developing, implementing, and managing regulatory compliance programs and procedures to guarantee adherence to laws, regulations, and guidelines set by regulatory bodies.
This position plays a critical role in maintaining the company'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 site-specific regulatory compliance strategy and program management are key responsibilities of this role. Additionally, monitoring changes in the global and local regulatory environment/regulatory requirements and ensuring GSK processes and products comply with applicable laws and regulations is essential.
This role requires 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:
- Manage Quality Regulatory Compliance and systems on-site by creating and executing regulatory compliance strategies and programs.
- Establish, review, and update site procedures to align with regulatory requirements.
- Accountable for timely communication, correspondence with Regulators, government officials for warrants, queries, cases, and any other correspondence in liaison with GSK Site team, GSK Legal, and GSK Regulatory team.
- Responsible for attending meetings and hearings with government officials and regulators in liaison with Site Quality Head.
- Proactive engagement with regulators, where possible, e.g., DTL, PQCB, to expedite current ongoing regulatory queries.
- Investigate and resolve compliance issues, including conducting root cause analysis and implementing corrective actions.
- Governance of regulatory KPIs and processes and identify and assess compliance risks to develop effective mitigation strategies.
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