Grinta is seeking to hire a Regulatory Affairs Manager with extensive experience in the pharmaceutical industry. The chosen candidate will hold the responsibility of ensuring that all warehouse activities align with pertinent regulatory requirements, standards, and guidelines.

Key Responsibilities:

• Develop and maintain a comprehensive understanding of relevant regulations, guidelines, and standards governing warehouse operations in the pharmaceutical industry.
• Collaborate with cross-functional teams, including warehouse operations, quality assurance, supply chain management, and regulatory affairs, to ensure alignment of regulatory objectives with business goals.
• Establish and maintain relationships with regulatory authorities, industry associations, and other stakeholders to stay abreast of regulatory developments and advocate for the company's interests.
• Lead regulatory inspections and audits of warehouse facilities, ensuring readiness and compliance with regulatory requirements.
• Review and approve warehouse documentation, including Standard Operating Procedures (SOPs), batch records, and quality records, to ensure accuracy, completeness, and compliance with regulations.
• Provide regulatory guidance and support to warehouse personnel, including training on regulatory requirements, procedures, and best practices.
• Participate in the evaluation and implementation of new warehouse systems, technologies, and processes to enhance regulatory compliance and operational efficiency.
• Monitor and assess changes in regulatory requirements and industry trends, proactively identifying risks and opportunities for improvement.
• Prepare and submit regulatory filings, notifications, and reports as required by regulatory authorities.
• Serve as a subject matter expert on regulatory matters related to warehouse operations, providing guidance and support to internal and external stakeholders as needed.